FDA 510(k) Application Details - K142315

Device Classification Name Endoscope, Neurological

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510(K) Number K142315
Device Name Endoscope, Neurological
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact KATHY RACOSKY
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Regulation Number 882.1480

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Classification Product Code GWG
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Date Received 08/19/2014
Decision Date 11/14/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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