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FDA 510(k) Application Details - K162348
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K162348
Device Name
Dressing, Wound, Collagen
Applicant
ACRO BIOMEDICAL CO., LTD
3F., NO.57, LUKE 2ND RD, LUJHU DIST.
Kaohsiung City 82151 TW
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Contact
DAR-JEN HSIEH
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
08/22/2016
Decision Date
05/10/2017
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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