FDA 510(k) Application Details - K992367

Device Classification Name Screw, Fixation, Bone

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510(K) Number K992367
Device Name Screw, Fixation, Bone
Applicant ELECTRO-BIOLOGY, INC.
100 INTERPACE PKWY.
PARSIPPANY, NJ 07054 US
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Contact JONAS WILF
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 07/15/1999
Decision Date 09/23/1999
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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