FDA 510(k) Application Details - K170300

Device Classification Name	More FDA Info for this Device
510(K) Number	K170300
Device Name	Restrata Wound Matrix
Applicant	Acera Surgical, Inc. 10880 Baur Blvd. St. Louis, MO 63132 US Other 510(k) Applications for this Company
Contact	Tamas Kovacs Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2017
Decision Date	04/26/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review