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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
Predetermined Change
Control Plan Authorized		 No
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