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