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FDA 510(k) Application Details - K082524
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K082524
Device Name
Catheter, Percutaneous
Applicant
NUMED, INC.
2880 MAIN ST.
HOPKINTON, NY 12965 US
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Contact
NICHELLE LAFLESH
Other 510(k) Applications for this Contact
Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
09/02/2008
Decision Date
09/26/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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