510(k) K982065 ยท MIB Elastomer, Silicone Block
STERILE SILICONE EXTERNAL WOUND COVER
| Applicant | Specialty Surgical Products, Inc., Hamilton MT, US |
| Decision | Substantially Equivalent, Aug 12, 1998 |
| Received | Jun 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982065
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.