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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 K030589
Device Name MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
Applicant
NUMED, INC.
2880 MAIN ST.
HOPKINTON,  NY  12965
Applicant Contact NICHELLE R LAFLESH
Correspondent
NUMED, INC.
2880 MAIN ST.
HOPKINTON,  NY  12965
Correspondent Contact NICHELLE R LAFLESH
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/25/2003
Decision Date 05/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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