510(k) K880329 ยท GBI Material, External Aesthetic Restoration, Used With Adhesive
FACTOR II PROSTHETIC SILICONE ELASTOMER
| Applicant | Factor, Ii, Inc., Lakeside AZ, US |
| Decision | Substantially Equivalent, Jun 1, 1988 |
| Received | Jan 26, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880329
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.