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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 K120680
Models SV1107, SV3309
Device Name ENSPIRE DISCECTOMY SYSTEM
Applicant
SPINE VIEW, INC.
48810 kato rd. suite 100e
fremont,  CA  94538
Contact diana degregorio
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/06/2012
Decision Date 06/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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