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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, suction, lipoplasty
510(k) Number K121703
Device Name LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE
Applicant
MEDI-KHAN USA, INC
399 MASSACHUSETTS AVE. #2
BOSTON,  MA  02115
Applicant Contact KACHI ENYINNA
Correspondent
MEDI-KHAN USA, INC
399 MASSACHUSETTS AVE. #2
BOSTON,  MA  02115
Correspondent Contact KACHI ENYINNA
Regulation Number878.5040
Classification Product Code
MUU  
Date Received06/08/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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