STOMA SHIELD ADAPTER
FDA 510(k) clearance K760927 · decided 1977-01-26
Clearance details
- K-number
- K760927
- Device name
- STOMA SHIELD ADAPTER
- Applicant
- Rudolfo T. Sanchez
- Decision
- Substantially Equivalent
- Date received
- 1976-10-28
- Decision date
- 1977-01-26
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- EXE
- Device class
- 1
- Regulation number
- 876.5900
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| CONVATEC ABSORBENT BANDAGE (K904233) | Convatec, A Division of E.R. Squibb & Sons | 1991-03-06 |
| UNITED SKIN BARRIER (K770982) | Howmedica Corp. | 1977-07-15 |
Recalls involving this device
No recalls on record reference this clearance.