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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K010880
Device Name NUMED HIGH PRESSURE PTA CATHETERS
Original Applicant
NUMED, INC.
2880 main st.
hopkinton,  NY  12965
Original Contact nichelle r laflesh
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received03/23/2001
Decision Date 04/20/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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