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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 K923558
Device Name ECG ELECTRODE
Applicant
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Applicant Contact TERI BUSEMAN
Correspondent
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Correspondent Contact TERI BUSEMAN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received07/17/1992
Decision Date 02/18/1993
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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