FDA 510(k) Application Details - K040080

Device Classification Name Cover, Burr Hole

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510(K) Number K040080
Device Name Cover, Burr Hole
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact MATTHEW M HULL
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Regulation Number 882.5250

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Classification Product Code GXR
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Date Received 01/15/2004
Decision Date 03/31/2004
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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