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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 K120553
Model ES-DS-900
Device Name ESPIN
Applicant
NLT SPINE LTD
555 thirteenth street nw
washington,  DC  20004
Contact john j smith
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/23/2012
Decision Date 08/09/2012
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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