510(k) K060828 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
MODIFICATION TO ENDOTINE RIBBON
| Applicant | Coapt Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Apr 19, 2006 |
| Received | Mar 27, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060828
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.