FDA 510(k) Application Details - K955864

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K955864
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant J.B.S., S.A.
204 E BLITHEDALE AVE.
MILL VALLEY, CA 94941 US
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Contact RICHARD DI MAIO
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 12/27/1995
Decision Date 03/15/1996
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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