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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 K121859
Model 103
Device Name TYSHAK NUCLEUS
Original Applicant
NUMED, INC.
2880 main st.
hopkinton,  NY  12965
Original Contact nichelle laflesh
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/26/2012
Decision Date 08/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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