Large Wound Dressing Kit
FDA 510(k) K803119 · American Medical Disposable, Inc.
510(k) numberK803119
Submission
- Device name
- Large Wound Dressing Kit
- Applicant
- American Medical Disposable, Inc.
Mchenry, IL, US - Received
- December 10, 1980
- Decision date
- December 30, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional | Covidien | 04/16/2008SE |
| K011514 | Instruments for One Time Use - DisposableKDD · Traditional | Kencap , Ltd. | 08/13/2001SE |
| K971317 | National Medical Healthcare Custom Orthopedic Kits and TraysKDD · Traditional | National Healthcare Mfg. Corp. | 05/08/1997SE |
| K960456 | Denver Paracentesis NEEDLE(60-1200) Denver Paracentesis Needle with Drainage…KDD · Traditional | Denver Biomaterials, Inc. | 04/01/1996SE |
| K936255 | Custom CV PackKDD · Traditional | Associated Medical | 03/31/1994SN |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | Associated Medical Products Co. | 07/09/1993SESK |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | Ulti-Med Intl., Inc. | 06/17/1993SE |
| K925905 | Kit, Surgical Instrument, DisposableKDD · Traditional | Kay Medical Concepts | 06/16/1993SESK |
| K924958 | Biopsy/Myelo/Arthro/Amniocent/Basic Skin Prep TrayKDD · Traditional | Medical Insights, Inc. | 06/07/1993SEKD |
| K925215 | Sterile Surgical Instrument TraysKDD · Traditional | American Healthcare Supply Co., Inc. | 06/01/1993SEKD |
More from American Healthcare Supply Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833735 | An Odor Absorbent BandageNAB · Traditional | 04/23/1984SE |
| K833734 | Neurological Sponge on Plastic Stick · Traditional | 04/23/1984SE |
| K833731 | Breathable Overwray Bandage Non-ElasKGX · Traditional | 01/27/1984SE |
| K833730 | Non Adherent Bandage/SheetFRO · Traditional | 01/27/1984SE |
| K833729 | Elastic Breathable Over-Wrap BandageNAD · Traditional | 12/30/1983SE |
| K833733 | Non - Adherent BandageFRO · Traditional | 12/27/1983SE |
| K833732 | Non Wetting Undercast PaddingITG · Traditional | 12/12/1983SE |
| K830202 | Cotton Balls, X-Ray Opaqued Strung & NonGDY · Traditional | 02/23/1983SE |
| K830201 | Polyester X-Ray Detectable Strung-SpongeGDY · Traditional | 02/23/1983SE |
| K803116 | Heavy Drainage PackGEC · Traditional | 01/28/1981SE |
Questions and answers
When was Large Wound Dressing Kit cleared by the FDA?
Large Wound Dressing Kit (K803119) received a 510(k) decision of Substantially Equivalent on December 30, 1980, 20 days after the submission was received.
What is the product code of K803119?
The FDA product code is KDD – Kit, Surgical Instrument, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.