FDA 510(k) Application Details - K163474

Device Classification Name

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510(K) Number K163474
Device Name CAVUX CervicalCage-L SA System
Applicant PROVIDENCE MEDICAL TECHNOLOGY, INC.
1331 N. CALIFORNIA BLVD
SUITE 320
WALNUT CREEK, CA 94596 US
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Contact EDWARD LIOU
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Regulation Number

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Classification Product Code OVE
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Date Received 12/12/2016
Decision Date 03/10/2017
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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