Disposable Apron
FDA 510(k) K964364 · Instrument Makar, Inc.
510(k) numberK964364
Submission
- Device name
- Disposable Apron
- Applicant
- Instrument Makar, Inc.
Okemos, MI, US - Received
- November 1, 1996
- Decision date
- February 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYU – Accessory, Surgical Apparel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K011755 | Stryker T4 Hytrel (R) TogasLYU · Special | Stryker Corp. | 06/22/2001SE |
| K965237 | Nurses Bouffant CapLYU · Traditional | Copioumed Intl., Inc. | 08/27/1997SE |
| K970988 | Far-East Bouffant CapsLYU · Traditional | Far East Science & Technology Development Co.… | 07/10/1997SE |
| K961791 | Depuy Disposable Filter/HoodLYU · Traditional | Depuy, Inc. | 08/09/1996SE |
| K961454 | Ammi Magni-GuardLYU · Traditional | American Medical Mfg., Inc. | 07/25/1996SE |
| K945302 | Sloan Sta-Dri Pant ProtectorLYU · Traditional | Sloan Corp. | 03/19/1996SE |
| K954314 | Ultrafit LinersLYU · Traditional | Stahmer Weston Scientific | 12/28/1995SE |
| K953089 | I-SpouseLYU · Traditional | Products For Medicine | 10/16/1995SE |
| K952303 | Splash AssistLYU · Traditional | Innovative Outsourcing Solutions | 08/24/1995SE |
| K942200 | Isolyser Orex Surgeon's Caps, Hoods, Bouffant CapsLYU · Traditional | Thantex Specialties, Inc. | 08/07/1995SE |
More from Thantex Specialties, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002600 | Litwin Cruicate AnchorMBI · Traditional | 11/15/2000SE |
| K980999 | ST Leger Cemented Semi-Constrained Total Knee ImplantJWH · Traditional | 11/06/1998SE |
| K963396 | Biosphere Suture AnchorMAI · Traditional | 05/06/1997SE |
| K955835 | Fluid Barrier Boot Knee & Ankle-HighFXP · Traditional | 11/19/1996SE |
| K960555 | Bioasbsorbable Mini-Screw Suture AnchorMAI · Traditional | 07/09/1996SE |
| K943249 | Bioabsorbable Interference ScrewMAI · Traditional | 07/31/1995SE |
| K944062 | Laprascopic GrasperGCS · Traditional | 02/23/1995SE |
| K942828 | Makar Full and Half Face ShieldLYU · Traditional | 02/23/1995SE |
| K930980 | Instrument Makar Perfix Interference Bone ScrewHWC · Traditional | 02/10/1994SN |
| K923841 | Bone ScrewsHWC · Traditional | 10/27/1993SE |
Questions and answers
When was Disposable Apron cleared by the FDA?
Disposable Apron (K964364) received a 510(k) decision of Substantially Equivalent on February 25, 1997, 116 days after the submission was received.
What is the product code of K964364?
The FDA product code is LYU – Accessory, Surgical Apparel, a Class I (low risk) device regulated under 21 CFR 878.4040.