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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K061632
Device Name GLOBUS PREMIUM MUSCLE STIMULATOR
Applicant
Domino S.R.L.
18 Eustace Dr.
West Hartford,  CT  06110
Applicant Contact GIOVANNI CIRIANI
Correspondent
Domino S.R.L.
18 Eustace Dr.
West Hartford,  CT  06110
Correspondent Contact GIOVANNI CIRIANI
Regulation Number890.5850
Classification Product Code
NGX  
Date Received06/12/2006
Decision Date 04/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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