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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K851063
Device Name TENSMED II
Applicant
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Applicant Contact DIXIE BRUENING
Correspondent
Intermedics, Inc.
P.O. Box 617
Freeport,  TX  77541
Correspondent Contact DIXIE BRUENING
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/15/1985
Decision Date 06/04/1985
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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