FDA 510(k) Application Details - K060927

Device Classification Name Catheter, Percutaneous

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510(K) Number K060927
Device Name Catheter, Percutaneous
Applicant CERES MEDICAL SYSTEMS, L.L.C.
13195 SEAGROVE ST
SAN DIEGO, CA 92130 US
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Contact CORRINE BONFIGLIO
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 04/04/2006
Decision Date 10/06/2006
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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