FDA 510(k) Application Details - K020134

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K020134
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact JENNIFER SCHUCK
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 01/15/2002
Decision Date 04/15/2002
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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