K935688 is an FDA 510(k) clearance for the AN-10S ANDERSEN TUBE WITH STYLET, a Tube, Nasogastric (Class II — Special Controls, product code BSS), submitted by H.W. Andersen Products, Inc. (Chapel Hill, US). The FDA issued a Cleared decision on December 30, 1994, 396 days after receiving the submission on November 29, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K935688 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 29, 1993 |
| Decision Date | December 30, 1994 |
| Days to Decision | 396 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | BSS — Tube, Nasogastric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |