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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 K862655
Device Name SIGNA II RESTING ECG ELECTRODE
Applicant
Kone Instruments, Inc.
Burdick Division
15 Plumb St.
Milton,  WI  53563
Applicant Contact FRANCIS I DOMINY
Correspondent
Kone Instruments, Inc.
Burdick Division
15 Plumb St.
Milton,  WI  53563
Correspondent Contact FRANCIS I DOMINY
Regulation Number870.2360
Classification Product Code
DRX  
Date Received07/14/1986
Decision Date 08/06/1986
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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