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FDA 510(k) Application Details - K171645
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K171645
Device Name
Dressing, Wound, Collagen
Applicant
Strukmyer Medical
1801 Big Town Blvd Suite #100
Mesquite, TX 75149 US
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Contact
Pamela Liberto
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
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More FDA Info for this Product Code
Date Received
06/05/2017
Decision Date
07/25/2017
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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