FDA 510(k) Application Details - K152490

Device Classification Name	More FDA Info for this Device
510(K) Number	K152490
Device Name	DERMABOND PRINEO Skin Closure System
Applicant	ETHICON, INC. ROUTE 22 WEST, P.O. BOX 151 SOMERVILLE, NJ 08876-0151 US Other 510(k) Applications for this Company
Contact	DONNA MARSHALL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2015
Decision Date	11/25/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review