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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 K221224
Device Name REAL INTELLIGENCE CORI
Applicant
Blue Belt Technologies, Inc.
2905 Northwest Blvd.
Suite 40
Plymouth,  MN  55441
Applicant Contact Corrine Herlinger
Correspondent
Blue Belt Technologies, Inc.
2905 Northwest Blvd.
Suite 40
Plymouth,  MN  55441
Correspondent Contact Corrine Herlinger
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/28/2022
Decision Date 08/19/2022
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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