FDA 510(k) Application Details - K161050

Device Classification Name	Tissue Adhesive For The Topical Approximation Of Skin   More FDA Info for this Device
510(K) Number	K161050
Device Name	Tissue Adhesive For The Topical Approximation Of Skin
Applicant	BERGEN MEDICAL PRODUCTS, INC. 16 WING DRIVE Cedar Knolls, NJ 07927 US Other 510(k) Applications for this Company
Contact	Tom Stephens Other 510(k) Applications for this Contact
Regulation Number	878.4010   More FDA Info for this Regulation Number
Classification Product Code	MPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2016
Decision Date	10/04/2016
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