510(k) K133864 ยท OMD Cutaneous Tissue Adhesive With Mesh
DERMABOND PRINEO SKIN CLOSURE SYSTEM
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Mar 10, 2014 |
| Received | Dec 19, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2017 | Ethicon, Inc. DERMABOND" PRINEO" Skin Closure System
Product Usage:
DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incision Terminated |
OMO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.