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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 K121005
Device Name ADIPREP ADIPOSE TRANSFER SYSTEM
Applicant
Harvest Technologies, Corp.
40 Grissom Rd., Suite 100
Plymouth,  MA  02360
Applicant Contact GABRIEL J MURACA, JR.
Correspondent
Harvest Technologies, Corp.
40 Grissom Rd., Suite 100
Plymouth,  MA  02360
Correspondent Contact GABRIEL J MURACA, JR.
Regulation Number878.5040
Classification Product Code
MUU  
Date Received04/03/2012
Decision Date 09/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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