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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K850311
Device Name DISPOS. CONDUCTIVE ADHESIVE TENS PAD
Applicant
Consolidated Medical Equipment, Inc.
310 Broad St.
Utica,  NY  13501
Applicant Contact WILLIAM W ABRAHAM
Correspondent
Consolidated Medical Equipment, Inc.
310 Broad St.
Utica,  NY  13501
Correspondent Contact WILLIAM W ABRAHAM
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/25/1985
Decision Date 03/05/1985
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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