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FDA 510(k) Application Details - K093022
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K093022
Device Name
Introducer, Catheter
Applicant
ACCESS SCIENTIFIC, INC.
12526 HIGH BLUFF DRIVE
SUITE 360
SAN DIEGO, CA 92130 US
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Contact
ALBERT MISAJON
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
09/29/2009
Decision Date
01/20/2010
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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