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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 K010665
Device Name TRANSAMERICA DIGITAL EMS
Applicant
TRANSAMERICA MEDICAL SYSTEMS
350 RACE ST.
HOLYOKE,  MA  01040
Applicant Contact JOHN F DUNN
Correspondent
TRANSAMERICA MEDICAL SYSTEMS
350 RACE ST.
HOLYOKE,  MA  01040
Correspondent Contact JOHN F DUNN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/06/2001
Decision Date 04/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Special
Reviewed by Third Party No
Combination Product No
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