K903401 is an FDA 510(k) clearance for the SPECIAL RONGEUR. This device is classified as a Rongeur, Manual (Class II - Special Controls, product code HAE).
Submitted by Sur-Med Instruments, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 10, 1990, 10 days after receiving the submission on July 31, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4840.
| 510(k) Number | K903401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 1990 |
| Decision Date | August 10, 1990 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HAE — Rongeur, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4840 |