FDA 510(k) Application Details - K071640

Device Classification Name Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)

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510(K) Number K071640
Device Name Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
Applicant COOK, INC.
750 DANIELS WAY
BLOOMINGTON, IN 47404 US
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Contact Theodore Heise
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Regulation Number 882.4100

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Classification Product Code NHC
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Date Received 06/15/2007
Decision Date 07/12/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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