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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Light Induced Heating
510(k) Number K083629
Device Name SMOOTHSHAPES
Applicant
Eleme Medical, Inc.
Heron Cove Office Park
10 Al Paul Ln., Suite 102
Merrimack,  NH  03054
Applicant Contact MICHAIL PANKRATOV
Correspondent
Eleme Medical, Inc.
Heron Cove Office Park
10 Al Paul Ln., Suite 102
Merrimack,  NH  03054
Correspondent Contact MICHAIL PANKRATOV
Regulation Number878.4810
Classification Product Code
NUV  
Date Received12/08/2008
Decision Date 02/19/2009
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
Predetermined Change
Control Plan Authorized		 No
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