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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K131130
Device Name NAVIGATION PIN
Applicant
Evergreen Orthopedic Research Lab
11321 NE 120th St.
Kirkland,  WA  98034
Applicant Contact JEFF STEPHANIAN
Correspondent
Evergreen Orthopedic Research Lab
11321 NE 120th St.
Kirkland,  WA  98034
Correspondent Contact JEFF STEPHANIAN
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/23/2013
Decision Date 07/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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