REUSABLE LIQUIDPROOF BOOTIE
FDA 510(k) clearance K925815 · decided 1993-07-09
Clearance details
- K-number
- K925815
- Device name
- REUSABLE LIQUIDPROOF BOOTIE
- Applicant
- Amsco Sterile Recoveries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-17
- Decision date
- 1993-07-09
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- FXP
- Device class
- 1
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PRIMED SHOE COVERS, PRIMED HEAD COVERS (K971076) | Primeline Medical Products, Inc. | 1998-01-13 |
| FAR-EAST SHOE COVERS (K971191) | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| CONVERTORS IMPERVIOUS SHOE COVERS (K970815) | Allegiance Healthcare Corp. | 1997-03-27 |
| SHOE COVER, NON-STERILE (K961342) | Copioumed Intl., Inc. | 1996-12-30 |
| FLUID BARRIER BOOT KNEE & ANKLE-HIGH (K955835) | Instrument Makar, Inc. | 1996-11-19 |
| NIOMED NON-SKID SHOE COVERS (K952937) | Amerasia Corp. | 1995-10-23 |
| NIOMED SHOE COVERS (K952897) | Amerasia Corp. | 1995-10-23 |
| OREX SHOE COVERS (K943034) | Thantex Specialties, Inc. | 1995-01-02 |
| KAPPLER PRO/VENT BOOT (K932738) | Kappler, Inc. | 1994-03-29 |
| STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS (K914702) | Depuy, Inc. | 1993-01-29 |
| DISPOSABLE SHOE COVER (K913628) | Gem Nonwovews, Inc. | 1991-10-04 |
| DISPOSABLE SHOE COVER (K894383) | American Threshold Industries, Inc. | 1989-09-12 |
Recalls involving this device
No recalls on record reference this clearance.