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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 K093368
Device Name BUTTERFLY TONER MODEL GYM070
Applicant
GLOBAL MARKETING PARTNERS DBA GYMMAX USA
28711 JAEGER DRIVE
LAGUNA NIGUEL,  CA  92677
Applicant Contact NICOLAAS BESSELING
Correspondent
GLOBAL MARKETING PARTNERS DBA GYMMAX USA
28711 JAEGER DRIVE
LAGUNA NIGUEL,  CA  92677
Correspondent Contact NICOLAAS BESSELING
Regulation Number890.5850
Classification Product Code
NGX  
Date Received10/29/2009
Decision Date 01/27/2010
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
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