The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Dermabond Prineo Skin Closure System.
| Device ID | K133864 |
| 510k Number | K133864 |
| Device Name: | DERMABOND PRINEO SKIN CLOSURE SYSTEM |
| Classification | Cutaneous Tissue Adhesive With Mesh |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Donna Marshall |
| Correspondent | Donna Marshall ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | OMD |
| CFR Regulation Number | 878.4011 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-19 |
| Decision Date | 2014-03-10 |
| Summary: | summary |