SORBSAN TOPICAL WOUND DRESSING (MODIFIED)
FDA 510(k) clearance K914575 · decided 1991-12-04
Clearance details
- K-number
- K914575
- Device name
- SORBSAN TOPICAL WOUND DRESSING (MODIFIED)
- Applicant
- Dow B. Hickam, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-15
- Decision date
- 1991-12-04
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- NAC
- Device class
- 1
- Regulation number
- 878.4018
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sugarland, TX, 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 |
|---|---|---|
| DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER (K082208) | Scivolutions, Inc. | 2008-12-01 |
| HYDRASORB JOYCE SPONGE (K925841) | Avitar, Inc. | 1993-05-12 |
| ALGINATE FIBER (K914779) | Adri/Technam | 1991-12-04 |
Recalls involving this device
No recalls on record reference this clearance.