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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name arthroscope
510(k) Number K122134
Model SPV-7000X-X
Device Name FLEXLITE CAMERA
Original Applicant
SPINE VIEW, INC.
48810 kato rd. suite 100e
fremont,  CA  94538
Original Contact mbithi muthini
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/18/2012
Decision Date 12/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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