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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
Device Name ENSPIRE DISCECTOMY SYSTEM
Original Applicant
SPINE VIEW, INC.
48810 kato rd. suite 100e
fremont,  CA  94538
Original Contact diana degregorio
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/06/2012
Decision Date 06/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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