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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 K003643
Device Name NUMED Z-MED PTV CATHERERS
Applicant
NUMED, INC.
2880 MAIN ST.
HOPKINTON,  NY  12965
Applicant Contact NICHELLE LAFLESH
Correspondent
NUMED, INC.
2880 MAIN ST.
HOPKINTON,  NY  12965
Correspondent Contact NICHELLE LAFLESH
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received11/27/2000
Decision Date 12/27/2000
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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