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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
Device Name FLEXLITE CAMERA
Applicant
SPINE VIEW, INC.
48810 Kato Rd. Suite 100E
Fremont,  CA  94538
Applicant Contact MBITHI MUTHINI
Correspondent
SPINE VIEW, INC.
48810 Kato Rd. Suite 100E
Fremont,  CA  94538
Correspondent Contact MBITHI MUTHINI
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/18/2012
Decision Date 12/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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