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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 K100230
Device Name SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
Applicant
ELEME MEDICAL, INC.
10 AL PAUL LANE, SUITE 102
MERRIMACK,  NH  03054
Applicant Contact William McGrail
Correspondent
ELEME MEDICAL, INC.
10 AL PAUL LANE, SUITE 102
MERRIMACK,  NH  03054
Correspondent Contact William McGrail
Regulation Number878.4810
Classification Product Code
NUV  
Date Received01/26/2010
Decision Date 04/02/2010
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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