ANOGO DISPOSABLE SHOE COVER
FDA 510(k) clearance K812105 · decided 1981-09-11
Clearance details
- K-number
- K812105
- Device name
- ANOGO DISPOSABLE SHOE COVER
- Applicant
- Anago, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-24
- Decision date
- 1981-09-11
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- BWP
- Device class
- 1
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, 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 |
|---|---|---|
| KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT (K880384) | Kimberly-Clark Corp. | 1988-06-23 |
| SURGICAL APPAREL SHOE COVERS (K831952) | Sudreca Surgical Dressings, Inc. | 1983-07-12 |
Recalls involving this device
No recalls on record reference this clearance.