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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K883896
Device Name NEUROTRAIN
Applicant
Sterne Equipment Co., Ltd.
7 Research Rd.
Brampton, On.,  CA L6W 1P4
Applicant Contact TRUDY BERGERE
Correspondent
Sterne Equipment Co., Ltd.
7 Research Rd.
Brampton, On.,  CA L6W 1P4
Correspondent Contact TRUDY BERGERE
Regulation Number882.5890
Classification Product Code
LIH  
Date Received09/14/1988
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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