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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K000171
Device Name CBYON SURGICAL OPERATING SYSTEM (SOS)
Applicant
CBYON, INC.
2275 E. BAYSHORE RD.
SUITE 101
PALO ALTO,  CA  94303
Applicant Contact RORY RANDALL
Correspondent
CBYON, INC.
2275 E. BAYSHORE RD.
SUITE 101
PALO ALTO,  CA  94303
Correspondent Contact RORY RANDALL
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/20/2000
Decision Date 03/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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