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FDA 510(k) Application Details - K110903
Device Classification Name
Catheter, Intravascular Occluding, Temporary
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510(K) Number
K110903
Device Name
Catheter, Intravascular Occluding, Temporary
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
870.4450
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Classification Product Code
MJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2011
Decision Date
04/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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