DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
FDA 510(k) clearance K082208 · decided 2008-12-01
Clearance details
- K-number
- K082208
- Device name
- DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
- Applicant
- Scivolutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-05
- Decision date
- 2008-12-01
- Days to decision
- 118 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
- Appollo Beach, 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 |
|---|---|---|
| HYDRASORB JOYCE SPONGE (K925841) | Avitar, Inc. | 1993-05-12 |
| SORBSAN TOPICAL WOUND DRESSING (MODIFIED) (K914575) | Dow B. Hickam, Inc. | 1991-12-04 |
| ALGINATE FIBER (K914779) | Adri/Technam | 1991-12-04 |
Recalls involving this device
No recalls on record reference this clearance.