510(k) K812691 ยท MDM Instrument, Manual, Surgical, General Use
SILICONE IMPLANTS
| Applicant | Sutter Biomedical, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Nov 16, 1981 |
| Received | Sep 22, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812691
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.