HOLLISTER DRAINAGE POUCH
FDA 510(k) clearance K801504 · decided 1980-08-12
Clearance details
- K-number
- K801504
- Device name
- HOLLISTER DRAINAGE POUCH
- Applicant
- Hollister, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-27
- Decision date
- 1980-08-12
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- FON
- 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 |
|---|---|---|
| BAG, DRAINAGEW/ADHESIVE; PROSTHESIS (K772366) | Atlantic Surgical | 1978-01-26 |
| POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE (K770826) | Howmedica Corp. | 1977-06-28 |
Recalls involving this device
No recalls on record reference this clearance.