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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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More FDA Info for this Product Code
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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