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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 K082868
Device Name MULLINS-X, MODEL 250X
Original Applicant
NUMED, INC.
2880 main st.
hopkinton,  NY  12965
Original Contact nichelle laflesh
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/29/2008
Decision Date 10/24/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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