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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 K020003
Device Name ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
Applicant
Bio Protech, Inc.
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Applicant Contact JANNA P TUCKER
Correspondent
Bio Protech, Inc.
198 Ave. De La D'Emerald
Sparks,  NV  89434 -9550
Correspondent Contact JANNA P TUCKER
Regulation Number870.2360
Classification Product Code
DRX  
Date Received01/02/2002
Decision Date 11/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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