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FDA 510(k) Application Details - K964210
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K964210
Device Name
Catheter, Intravascular, Diagnostic
Applicant
TARGET THERAPEUTICS
47201 LAKEVIEW BLVD.
P.O. BOX 5120
FREEMONT, CA 94538 US
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Contact
LARAINE PANGELINA
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Regulation Number
870.1200
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Classification Product Code
DQO
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More FDA Info for this Product Code
Date Received
10/22/1996
Decision Date
10/31/1997
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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