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FDA 510(k) Application Details - K030734
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K030734
Device Name
Introducer, Catheter
Applicant
VERTELINK CORPORATION
27001 LA PAZ SUITE 312
MISSION VIEJO, CA 92691 US
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Contact
ALBERT REGO
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/10/2003
Decision Date
09/10/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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