FDA 510(k) Application Details - K193583

Device Classification Name	More FDA Info for this Device
510(K) Number	K193583
Device Name	Restrata«
Applicant	Acera Surgical, Inc. 10880 Baur Blvd. St. Louis, MO 63132 US Other 510(k) Applications for this Company
Contact	Lily Jeng 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	12/23/2019
Decision Date	09/25/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review