Submission Details
| 510(k) Number | K932169 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 05, 1993 |
| Decision Date | July 20, 1993 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
K932169 is an FDA 510(k) clearance for the MICROSURGICAL INSTRUMENTS, a Instrument, Microsurgical (Class I — General Controls, product code GZX), submitted by American Russian Medical Services, Inc. (Jackson, US). The FDA issued a Cleared decision on July 20, 1993, 76 days after receiving the submission on May 5, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4525.
| 510(k) Number | K932169 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 05, 1993 |
| Decision Date | July 20, 1993 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GZX — Instrument, Microsurgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 882.4525 |