K834575 is an FDA 510(k) clearance for the BARD KARAYA GUM WASHERS. This device is classified as a Collector, Ostomy (Class I - General Controls, product code EXB).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 37 days after receiving the submission on December 29, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K834575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1983 |
| Decision Date | February 04, 1984 |
| Days to Decision | 37 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 |