FDA 510(k) Application Details - K201400

Device Classification Name	More FDA Info for this Device
510(K) Number	K201400
Device Name	npSIMS Negative Pressure Surgical Incision Management SystemÖ (npSIMS)Ö
Applicant	Aatru Medical LLC 1301 East 9th Street, Suite 2700 Cleveland, OH 44114 US Other 510(k) Applications for this Company
Contact	James J. Rogers Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2020
Decision Date	08/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review