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FDA 510(k) Application Details - K122490
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K122490
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
CGBIO CO., LTD
163-3 SAMSUNG-DONG
KANGNAM-GU
SEOUL 135-715 KR
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Contact
JUNGEUN IM
Other 510(k) Applications for this Contact
Regulation Number
878.4780
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Classification Product Code
OMP
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More FDA Info for this Product Code
Date Received
08/15/2012
Decision Date
11/13/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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