K984629 is an FDA 510(k) clearance for the MOSS TUBES, INC. NASAL TUBE - MARK IV, a Tube, Nasogastric (Class II — Special Controls, product code BSS), submitted by Moss Tubes, Inc. (Elizabeth, US). The FDA issued a Cleared decision on March 2, 1999, 62 days after receiving the submission on December 30, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K984629 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 30, 1998 |
| Decision Date | March 02, 1999 |
| Days to Decision | 62 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 |