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FDA 510(k) Application Details - K172338
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K172338
Device Name
Dressing, Wound, Drug
Applicant
Synedgen, Inc
1420 N. Claremont Blvd., Suite 105D
Claremont, CA 91711 US
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Contact
Shenda Baker
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
08/02/2017
Decision Date
02/21/2018
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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