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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
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