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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 K160537
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   JWH   KRR   NPJ  
Date Received02/26/2016
Decision Date 05/19/2016
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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