Lake Wound Care/Treatment Kit
FDA 510(k) K873973 · Lake Medical Products, Inc.
510(k) numberK873973
Submission
- Device name
- Lake Wound Care/Treatment Kit
- Applicant
- Lake Medical Products, Inc.
Maryland Heights, MO, US - Received
- September 29, 1987
- Decision date
- November 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRO – General Surgery Tray
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
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|---|---|---|---|
| K213481 | Medline General Surgery TrayLRO · Traditional | Medline Industries, Inc. | 05/24/2022SE |
| K212258 | Medline Cardiovascular Procedure KitLRO · Traditional | Medline Industries, Inc. | 12/03/2021SE |
| K041080 | Surgical Drape Kit - D.I.R.R.A. SRLLRO · Traditional | D.I.R.R.A. S.R.L. | 11/30/2004SE |
| K030721 | Quick-Tap Paracentesis Tray, Kit & NeedleLRO · Special | Ballard Medical Products | 03/31/2003SE |
| K023276 | Amsino Tracheostomy Care TrayLRO · Traditional | Amsino International, Inc. | 12/09/2002SE |
| K980137 | Worldwide Medical Technologies Bone Marrow Biopsy Procedure TrayLRO · Traditional | Worldwide Medical Technologies, LLC | 01/30/1998SE |
| K971061 | Opportunity Inc. Bone Marrow Biopsy and Aspiration TrayLRO · Traditional | Opportunity, Inc. | 06/11/1997SN |
| K971062 | Opportunity Inc. General Purpose TrayLRO · Traditional | Opportunity, Inc. | 06/09/1997SN |
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | Associated Medical Products Co. | 03/19/1997SE |
| K970286 | Presbyterian Linen Services Surgical PacksLRO · Traditional | Medline Industries, Inc. | 03/10/1997SE |
More from Medline Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943162 | Lake Stagezero(Tm) Air Flotation BedFNM · Traditional | 02/27/1995SE |
| K922730 | Lake Ostomy Care SetEXB · Traditional | 12/30/1993SESK |
| K905053 | Stage Zero Air Flotation BedIOQ · Traditional | 11/26/1990SE |
| K901835 | Lake N/G Feeding Tube (with Y Port Connector)KNT · Traditional | 09/05/1990SE |
| K902508 | Lake Male External Catheterization KitFCM · Traditional | 08/23/1990SESD |
| K902121 | Lake Gastrostomy TubeKGC · Traditional | 07/27/1990SE |
| K884127 | Lake N/G Feeding TubeKNT · Traditional | 02/08/1989SE |
| K884128 | Lake N/G Extension SetKNT · Traditional | 12/08/1988SE |
| K883610 | Lake Foley Catheterization TrayFCN · Traditional | 10/12/1988SE |
| K880578 | Lake Disposable Probe CoverFLL · Traditional | 03/31/1988SE |
Questions and answers
When was Lake Wound Care/Treatment Kit cleared by the FDA?
Lake Wound Care/Treatment Kit (K873973) received a 510(k) decision of Substantially Equivalent on November 20, 1987, 52 days after the submission was received.
What is the product code of K873973?
The FDA product code is LRO – General Surgery Tray, a Class II (moderate risk) device regulated under 21 CFR 878.4370.