The following data is part of a De Novo classification by Closure Medical Corp. with the FDA for Prineo Skin Closure System.
| DeNovo ID | DEN090005 |
| Device Name: | PRINEO SKIN CLOSURE SYSTEM |
| Classification | Cutaneous Tissue Adhesive With Mesh |
| Applicant | CLOSURE MEDICAL CORP. 5250 Greens Dairy Rd. Raleigh, NC 27616 |
| Contact | Bruce Krattenmaker |
| Product Code | OMD |
| CFR Regulation Number | 878.4011 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K082289 |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Post-NSE |
| Date Received | 2009-03-24 |
| Decision Date | 2010-04-30 |
| Reclassification Order: | Reclassification Order |