510(k) K030786 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
MONO-SWIFT
| Applicant | Cp Medical, Portland OR, US |
| Decision | Substantially Equivalent, May 6, 2003 |
| Received | Mar 12, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K030786
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2014 | C P Medical Inc. Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with Terminated |
NEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.