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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
Device Name ESPIN
Applicant
NLT SPINE LTD
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
NLT SPINE LTD
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/23/2012
Decision Date 08/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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