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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 K113362
Device Name SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
Applicant
SPINE VIEW, INC.
48810 Kato Rd. Suite 100E
Fremont,  CA  94538
Applicant Contact SEVRINA CIUCCI
Correspondent
SPINE VIEW, INC.
48810 Kato Rd. Suite 100E
Fremont,  CA  94538
Correspondent Contact SEVRINA CIUCCI
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/15/2011
Decision Date 02/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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