FDA 510(k) Application Details - K201577

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K201577
Device Name	Dressing, Wound, Collagen
Applicant	MedSkin Solutions Dr. Suwelack AG Josef-Suwelack-Strasse 2 Billerbeck 48727 DE Other 510(k) Applications for this Company
Contact	Zuzana Hⁿlsbusch Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2020
Decision Date	01/07/2021
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