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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 K201953
Device Name OMNI PLUS Surgical System
Applicant
Sight Sciences, Inc.
4040 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 Received07/14/2020
Decision Date 08/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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