FDA 510(k) Application Details - K131500

Device Classification Name Clip, Aneurysm

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510(K) Number K131500
Device Name Clip, Aneurysm
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact KATHY A RACOSKY
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Regulation Number 882.5200

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Classification Product Code HCH
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Date Received 05/24/2013
Decision Date 01/24/2014
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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