K851398 is an FDA 510(k) clearance for the BARD PERISTOMAL PASTE. This device is classified as a Collector, Ostomy (Class I - General Controls, product code EXB).
Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on May 23, 1985, 44 days after receiving the submission on April 9, 1985.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K851398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1985 |
| Decision Date | May 23, 1985 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXB — Collector, Ostomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |