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FDA 510(k) Application Details - K141617
Device Classification Name
More FDA Info for this Device
510(K) Number
K141617
Device Name
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Applicant
REX MEDICAL, L.P.
55 NORTHERN BOULBEVARD
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QEW
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Date Received
06/17/2014
Decision Date
11/14/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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