510(k) DEN090005
DEN090005 is an FDA 510(k) premarket notification submitted by Closure Medical Corp. for the device "PRINEO SKIN CLOSURE SYSTEM". The FDA issued a decision of De Novo Granted on April 30, 2010. The device falls under product code OMD (Cutaneous Tissue Adhesive With Mesh), a Class II device regulated under 21 CFR 878.4011. Closure Medical Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 30, 2010
- Date Received
- March 24, 2009
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cutaneous Tissue Adhesive With Mesh
- Device Class
- Class II
- Regulation Number
- 878.4011
- Review Panel
- SU
- Submission Type
For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.