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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 K122662
Device Name VERTIFLEX DIRECT DECOMPRESSION SYSTEM
Original Applicant
VERTIFLEX, INC.
1351 calle avanzado
san clemente,  CA  92673
Original Contact steve reitzler
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/31/2012
Decision Date 11/13/2012
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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