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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 K843290
Device Name NUMED BALLOON PACING CATHETER
Applicant
NuMED, Inc.
Main St.
Hopkinton,  NY  12940
Applicant Contact ALLEN J TOWER
Correspondent
NuMED, Inc.
Main St.
Hopkinton,  NY  12940
Correspondent Contact ALLEN J TOWER
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/21/1984
Decision Date 01/14/1985
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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