FDA 510(k) Application Details - K993822

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K993822
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
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Contact PATRICIA FLOOD
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 11/12/1999
Decision Date 12/10/1999
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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