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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 K973727
Device Name ELECTRODE, ELECTROCARDIOGRAPH
Applicant
DON TAY INDUSTRIES
2383 S. 16ND ST.
NEW BERLIN,  WI  53151
Applicant Contact EDWARD ARNDT
Correspondent
DON TAY INDUSTRIES
2383 S. 16ND ST.
NEW BERLIN,  WI  53151
Correspondent Contact EDWARD ARNDT
Regulation Number870.2360
Classification Product Code
DRX  
Date Received09/30/1997
Decision Date 12/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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