FDA 510(k) Application Details - K172689

Device Classification Name	More FDA Info for this Device
510(K) Number	K172689
Device Name	DESCRIBE PFD Patch
Applicant	Merz North America, Inc. 6501 Six Forks Road Raleigh, NC 27615 US Other 510(k) Applications for this Company
Contact	Misty DÆOttavio Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2017
Decision Date	11/29/2017
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