FDA 510(k) Application Details - K993066

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K993066
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant ADVANCED SPINE TECHNOLOGY, INC.
3645 GRAND AVE., SUITE 304
OAKLAND, CA 94610 US
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Contact GORDON TAO
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 06/24/1999
Decision Date 06/07/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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