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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Ophthalmic
510(k) Number K202678
Device Name OMNI Surgical System
Applicant
Sight Sciences, Inc.
440 Campbell Ave, Suite 100
Menlo Park,  CA  94025
Applicant Contact Edward J. Sinclair
Correspondent
Sight Sciences, Inc.
4040 Campbell Ave, Suite 100
Menlo Park,  CA  94025
Correspondent Contact Edward J. Sinclair
Regulation Number880.5725
Classification Product Code
MRH  
Subsequent Product Code
HMZ  
Date Received09/15/2020
Decision Date 03/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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