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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 K950470
Device Name DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM
Applicant
NIKOMED U.S.A., INC.
206 AIRPORT BLVD.
DOYLESTOWN,  PA  18901
Applicant Contact DONALD C EPSTEIN
Correspondent
NIKOMED U.S.A., INC.
206 AIRPORT BLVD.
DOYLESTOWN,  PA  18901
Correspondent Contact DONALD C EPSTEIN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/03/1995
Decision Date 11/06/1995
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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