FDA 510(k) Application Details - K041291

Device Classification Name Catheter, Intravascular, Diagnostic

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510(K) Number K041291
Device Name Catheter, Intravascular, Diagnostic
Applicant KERBEROS PROXIMAL SOLUTIONS, INC.
1400 TERRA BELLA AVE, SUITE K
MOUNTAIN VIEW, CA 94043 US
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Contact TOM MASON
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Regulation Number 870.1200

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Classification Product Code DQO
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Date Received 05/14/2004
Decision Date 05/21/2004
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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