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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 K121218
Models CAN-04-26-3, CAN-04-35-3, CON-03, STK-03
Device Name HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
Original Applicant
ANDREW TECHNOLOGIES, LLC
3 haddon avenue
haddonfield,  NJ  08033
Original Contact herbert crane
Regulation Number878.5040
Classification Product Code
MUU  
Date Received04/23/2012
Decision Date 12/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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