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FDA 510(k) Application Details - K083455
Device Classification Name
System, Suction, Lipoplasty
More FDA Info for this Device
510(K) Number
K083455
Device Name
System, Suction, Lipoplasty
Applicant
MEDI-KHAN USA, INC
1516 OAK STREET,
SUITE 312
ALAMEDA, CA 94501 US
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Contact
JULIE SANTIAGO
Other 510(k) Applications for this Contact
Regulation Number
878.5040
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Classification Product Code
MUU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/21/2008
Decision Date
05/18/2009
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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