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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 K012886
Device Name CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE
Applicant
CBYON, INC.
2275 E. BAYSHORE RD.
SUITE 101
PALO ALTO,  CA  94303
Applicant Contact KRISHNA SUDHAKARAN
Correspondent
CBYON, INC.
2275 E. BAYSHORE RD.
SUITE 101
PALO ALTO,  CA  94303
Correspondent Contact KRISHNA SUDHAKARAN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/28/2001
Decision Date 10/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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