510(k) K982101 ยท GXQ Dura Substitute
SHELHIGH NO-REACT DURA SHIELD
| Applicant | Shelhigh, Inc., Millburn NJ, US |
| Decision | Substantially Equivalent, May 2, 2000 |
| Received | Jun 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982101
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.