FDA 510(k) Application Details - K062406

Device Classification Name Neurosurgical Paddie

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510(K) Number K062406
Device Name Neurosurgical Paddie
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact LISA M BOYLE
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Regulation Number 882.4700

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Classification Product Code HBA
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Date Received 08/17/2006
Decision Date 09/15/2006
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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