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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 K133061
Device Name ESPIN SYSTEM
Applicant
Nlt Spine, Ltd.
555 13th St., NW
Washington,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
Nlt Spine, Ltd.
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/27/2013
Decision Date 11/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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