FDA 510(k) Application Details - K982908

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K982908
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant ELECTRO-BIOLOGY, INC.
6 UPPER POND RD.
P.O. BOX 345
PARSIPPANY, NJ 07054 US
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Contact JONAS WILF
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 08/18/1998
Decision Date 08/28/1998
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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