FDA 510(k) Application Details - K020728

Device Classification Name Catheter, Ventricular

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510(K) Number K020728
Device Name Catheter, Ventricular
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact JOYCE KILROY
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Regulation Number 882.4100

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Classification Product Code HCA
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Date Received 03/06/2002
Decision Date 04/05/2002
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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