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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
510(k) Number K071431
Device Name GLOBUS GENESY 1100 STIMULATOR
Applicant
Domino S.R.L.
18 Eustace Dr.
West Hartford,  CT  06110
Applicant Contact GIOVANNI M CIRIANI
Correspondent
Domino S.R.L.
18 Eustace Dr.
West Hartford,  CT  06110
Correspondent Contact GIOVANNI M CIRIANI
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received05/23/2007
Decision Date 09/21/2007
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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