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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 K991105
Device Name ECG ELECTRODE (VARIOUS)
Applicant
Conmedcorp
310 Broad St.
Utica,  NY  13501
Applicant Contact IRA D DUESLER
Correspondent
Conmedcorp
310 Broad St.
Utica,  NY  13501
Correspondent Contact IRA D DUESLER
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/01/1999
Decision Date 11/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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