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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K810643
Device Name UNIVERSAL PACING ELECTRODE KIT
Applicant
Stanco Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Stanco Medical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.3680
Classification Product Code
LDF  
Date Received03/10/1981
Decision Date 04/08/1981
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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