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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 K152574
Device Name Navio
Applicant
BLUE BELT TECHNOLOGIES, INC
2905 NORTHWEST BLVD., STE. 40
PLYMOUTH,  MN  55441
Applicant Contact RICHARD G. CONFER
Correspondent
BLUE BELT TECHNOLOGIES, INC
2905 NORTHWEST BLVD., STE. 40
PLYMOUTH,  MN  55441
Correspondent Contact RICHARD G. CONFER
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
HRY   HSX   KRR   NPJ  
Date Received09/09/2015
Decision Date 10/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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