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FDA 510(k) Application Details - K140954
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K140954
Device Name
Dressing, Wound, Drug
Applicant
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd.
P.O. BOX 120-119
SHANGHAI 200120 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2014
Decision Date
03/23/2015
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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