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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 K003433
Device Name NEURO-TRAIN III (3)
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  
Subsequent Product Codes
GZJ   LIH  
Date Received11/06/2000
Decision Date 06/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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