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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 K203751
Device Name OMNIVision system
Applicant
Corin USA
12750 Citrus Park Ln.
Suite 120
Tampa,  FL  33625
Applicant Contact Lucinda Gerber
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-L'Ile Perrot,  CA J7V 7P2
Correspondent Contact Robert A Poggie
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/23/2020
Decision Date 04/12/2021
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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