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FDA 510(k) Application Details - K162759
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K162759
Device Name
Dressing, Wound, Collagen
Applicant
KeraNetics, LLC.
200 East First Stree, Box #4, Suite 102
Winston-Salem, NC 27101 US
Other 510(k) Applications for this Company
Contact
Luke Burnett
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
09/30/2016
Decision Date
06/02/2017
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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