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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 K963236
Device Name M & R DISPOSABLE ELECTRODE (14200)
Applicant
M & R Mfg., Inc.
11967 Upper Fredericktown
Amity Rd.
Fredericktown,  OH  43019
Applicant Contact MARK E DAILEY
Correspondent
M & R Mfg., Inc.
11967 Upper Fredericktown
Amity Rd.
Fredericktown,  OH  43019
Correspondent Contact MARK E DAILEY
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/19/1996
Decision Date 11/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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