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FDA 510(k) Application Details - K172593
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K172593
Device Name
Dressing, Wound, Collagen
Applicant
StemSys
10871 NW 52nd St, Ste 4
Sunrise, FL 33351 US
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Contact
Clay Fette
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
08/29/2017
Decision Date
03/16/2018
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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