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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K941977
Device Name TAYLOR LONG TERM MONITORING ELECTRODE
Applicant
Taylor Industries, Inc.
2420 S. 179th St.
New Berlin,  WI  53146
Applicant Contact MICHAEL R BALLARD
Correspondent
Taylor Industries, Inc.
2420 S. 179th St.
New Berlin,  WI  53146
Correspondent Contact MICHAEL R BALLARD
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/19/1994
Decision Date 09/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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