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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 K980158
Device Name MYO-TRAIN V (5)
Applicant
Sterne Equipment Co., Ltd.
7 Research Rd.
Brampton, On.,  CA L6W 1P4
Applicant Contact THOMAS WALLACE
Correspondent
Sterne Equipment Co., Ltd.
7 Research Rd.
Brampton, On.,  CA L6W 1P4
Correspondent Contact THOMAS WALLACE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/16/1998
Decision Date 07/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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