FDA 510(k) Application Details - K991092

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K991092
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant ELECTRO-BIOLOGY, INC.
100 INTERPACE PKWY.
PARSIPPANY, NJ 07054 US
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Contact JONAS WILF
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 04/01/1999
Decision Date 04/29/1999
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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