K933596 is an FDA 510(k) clearance for the GASTRIC, CATHETER, IRRIGATION & ASPIRATION, a Tube, Nasogastric (Class II — Special Controls, product code BSS), submitted by Polamedco, Inc. (Inglewood, US). The FDA issued a Cleared decision on February 13, 1995, 567 days after receiving the submission on July 26, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K933596 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 26, 1993 |
| Decision Date | February 13, 1995 |
| Days to Decision | 567 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | BSS — Tube, Nasogastric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |