K970851 is an FDA 510(k) clearance for the LYOPLANT DURA SUBSTITUTE(VARIOUS). This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 9, 1997, 277 days after receiving the submission on March 7, 1997.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K970851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1997 |
| Decision Date | December 09, 1997 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ — Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |