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FDA 510(k) Application Details - K133625
Device Classification Name
Guide, Wire, Catheter, Neurovasculature
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510(K) Number
K133625
Device Name
Guide, Wire, Catheter, Neurovasculature
Applicant
Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact
HANNAH FOLEY
Other 510(k) Applications for this Contact
Regulation Number
870.1330
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Classification Product Code
MOF
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More FDA Info for this Product Code
Date Received
11/26/2013
Decision Date
02/24/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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