510(k) K180625 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Rondek PGA Suture (Beige or Violet)
| Applicant | Rk Manufacturing Corporation, Danbury CT, US |
| Decision | Substantially Equivalent, May 10, 2018 |
| Received | Mar 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180625
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.