510(k) K123409 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
| Applicant | Surgical Specialties Corp. Dba Angiotech, Reading PA, US |
| Decision | Substantially Equivalent, Nov 20, 2012 |
| Received | Nov 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123409
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.