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FDA 510(k) Application Details - K042399
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K042399
Device Name
Introducer, Catheter
Applicant
REX MEDICAL LP
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
870.1340
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Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
09/03/2004
Decision Date
12/17/2004
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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