COLO-TAPE
FDA 510(k) clearance K791146 · decided 1979-07-30
Clearance details
- K-number
- K791146
- Device name
- COLO-TAPE
- Applicant
- Suburban Ostomy Supply Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-06-18
- Decision date
- 1979-07-30
- Days to decision
- 42 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
+ Add to Predicate Builder ◉ Watch Suburban Ostomy Supply Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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.