FDA 510(k) Application Details - K091559

Device Classification Name Catheter, Continuous Flush

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510(K) Number K091559
Device Name Catheter, Continuous Flush
Applicant CHESTNUT MEDICAL TECHNOLOGIES, INC.
173 JEFFERSON DRIVE
MENLO PARK, CA 94025-1114 US
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Contact DANIEL CHER
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 05/28/2009
Decision Date 09/18/2009
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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