FDA 510(k) Application Details - K213512

Device Classification Name	More FDA Info for this Device
510(K) Number	K213512
Device Name	DERMABOND PRINEO Skin Closure System
Applicant	Ethicon, Inc. 1000 Rte. 202 South Raritan, NJ 08869 US Other 510(k) Applications for this Company
Contact	Noorhidayah Norizan 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	11/02/2021
Decision Date	12/07/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review