CONVATEC ABSORBENT BANDAGE
FDA 510(k) clearance K904233 · decided 1991-03-06
Clearance details
- K-number
- K904233
- Device name
- CONVATEC ABSORBENT BANDAGE
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
- Decision
- Substantially Equivalent
- Date received
- 1990-09-05
- Decision date
- 1991-03-06
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- EXE
- Device class
- 1
- Regulation number
- 876.5900
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Princeton, NJ, 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 |
|---|---|---|
| UNITED SKIN BARRIER (K770982) | Howmedica Corp. | 1977-07-15 |
| STOMA SHIELD ADAPTER (K760927) | Rudolfo T. Sanchez | 1977-01-26 |
Recalls involving this device
No recalls on record reference this clearance.