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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, flow directed
510(k) Number K883948
Device Name MODIFIED NUMED BALLOON ANGIOGRAPHIC 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 Number870.1240
Classification Product Code
DYG  
Date Received09/13/1988
Decision Date 04/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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