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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 For Removal
510(k) Number K082025
Device Name BODY-JET
Applicant
Human Med AG
Wilhelm-Hennemann-Str.9
Schwerin,  DE 19061
Applicant Contact INGE MATTHIESEN
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Regulation Number878.5040
Classification Product Code
QPB  
Date Received07/17/2008
Decision Date 08/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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