STOMAHESIVE PASTE PROTECTIVE SKIN BARR
FDA 510(k) clearance K803100 · decided 1981-01-08
Clearance details
- K-number
- K803100
- Device name
- STOMAHESIVE PASTE PROTECTIVE SKIN BARR
- Applicant
- E. R. Squibb & Sons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-09
- Decision date
- 1981-01-08
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- EZR
- Device class
- 1
- Regulation number
- 876.5900
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- New York, NY, 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 PASTE (K844341) | Howmedica Corp. | 1985-01-18 |
| COLO-TAPE (K791146) | Suburban Ostomy Supply Co., Inc. | 1979-07-30 |
| OSTOMY KARAYA GUM POWDER (K761340) | Howmedica Corp. | 1977-03-07 |
| KARAYA GUM POWDER (K770230) | Atlantic Surgical | 1977-02-28 |
| KARAYA GUM PRODUCTS - PROCESS CHANGE (K761319) | Howmedica Corp. | 1977-02-15 |
Recalls involving this device
No recalls on record reference this clearance.