K961802 is an FDA 510(k) clearance for the PRECLUDE SYNBLOC MEMBRANE. This device is classified as a Strip, Craniosynostosis, Preformed (Class II - Special Controls, product code GXO).
Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on July 31, 1996, 83 days after receiving the submission on May 9, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5900.
| 510(k) Number | K961802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1996 |
| Decision Date | July 31, 1996 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXO — Strip, Craniosynostosis, Preformed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5900 |