K895395 is an FDA 510(k) clearance for the V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR. This device is classified as a Retractor, Self-retaining, For Neurosurgery (Class II - Special Controls, product code GZT).
Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on October 19, 1989, 48 days after receiving the submission on September 1, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4800.
| 510(k) Number | K895395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1989 |
| Decision Date | October 19, 1989 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GZT — Retractor, Self-retaining, For Neurosurgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4800 |