FDA 510(k) Application Details - K161731

Device Classification Name Catheter, Ventricular

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510(K) Number K161731
Device Name Catheter, Ventricular
Applicant Parker Hannifin Corp.
3007 Bunsen Ave.
Ventura, CA 93003 US
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Contact George Austria
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Regulation Number 882.4100

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Classification Product Code HCA
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Date Received 06/23/2016
Decision Date 03/27/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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