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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 K051343
Device Name MINI GHOST PTA CATHETER, MODEL 507
Original Applicant
NUMED, INC.
2880 main st.
hopkinton,  NY  12965
Original Contact nichelle laflesh
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/25/2005
Decision Date 07/28/2005
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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