510(k) K982282 ยท GXQ Dura Substitute
DURA-GUARD - DURAL REPAIR PATCH
| Applicant | Bio-Vascular, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jul 30, 1998 |
| Received | Jun 30, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K982282
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2013 | Synovis Surgical Innovations, Inc. Dura Guard, Dural Repair Patch with Apex Processing.
For use as a dura substitute for the closure of dura mater during neurosurgery.
Product Code:
DG0209SN
DG0209SN
DG0209SN
DG0209SN
DG02 Terminated |
GXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.