Submission Details
| 510(k) Number | K932722 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 04, 1993 |
| Decision Date | August 06, 1993 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
K932722 is an FDA 510(k) clearance for the CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM, a Drain, Tee (water Trap) (Class I — General Controls, product code BYH), submitted by Carie Med-Tech Services, Inc. (Olney, US). The FDA issued a Cleared decision on August 6, 1993, 63 days after receiving the submission on June 4, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5995.
| 510(k) Number | K932722 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 04, 1993 |
| Decision Date | August 06, 1993 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BYH — Drain, Tee (water Trap) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5995 |