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FDA 510(k) Application Details - K150916
Device Classification Name
More FDA Info for this Device
510(K) Number
K150916
Device Name
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
Applicant
HemCon Medical Technologies, Inc.
720 SW Washington Street, Suite 200
Portland, OR 97225 US
Other 510(k) Applications for this Company
Contact
Jody Oyama
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/06/2015
Decision Date
11/10/2015
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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