FDA 510(k) Application Details - K032059

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K032059
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact GEORG KELLER
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 07/02/2003
Decision Date 07/25/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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