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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K872012
Device Name LECTEC NON-INVASIVE PACING ELECTRODE
Applicant
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Applicant Contact DAVID MONTECALVO
Correspondent
Lectec Corp.
10701 Red Cir. Dr.
Minnetonka,  MN  55343
Correspondent Contact DAVID MONTECALVO
Regulation Number870.5550
Classification Product Code
DRO  
Date Received05/26/1987
Decision Date 06/29/1987
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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