K911932 is an FDA 510(k) clearance for the J105 JAMES SURGICAL SYSTEM I/A PACK. This device is classified as a Instrument, Microsurgical (Class I - General Controls, product code GZX).
Submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on August 26, 1991, 118 days after receiving the submission on April 30, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4525.
| 510(k) Number | K911932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1991 |
| Decision Date | August 26, 1991 |
| Days to Decision | 118 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 |