K922730 is an FDA 510(k) clearance for the LAKE OSTOMY CARE SET, a Collector, Ostomy (Class I — General Controls, product code EXB), submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on December 30, 1993, 573 days after receiving the submission on June 5, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K922730 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | June 05, 1992 |
| Decision Date | December 30, 1993 |
| Days to Decision | 573 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EXB — Collector, Ostomy |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.5900 |