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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 K894588
Device Name DEFIB/PACING PADS
Applicant
Conmedcorp
310 Broad St.
Utica,  NY  13501
Applicant Contact WILLIAM ABRAHAM
Correspondent
Conmedcorp
310 Broad St.
Utica,  NY  13501
Correspondent Contact WILLIAM ABRAHAM
Regulation Number870.5550
Classification Product Code
DRO  
Date Received07/24/1989
Decision Date 10/26/1989
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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