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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 K132494
Device Name VISCOELASTIC INJECTOR
Applicant
Sight Sciences, Inc.
733 Bolsana Dr.
Laguna Beach,  CA  92651
Applicant Contact JUDY F GORDON D.V.M.
Correspondent
Sight Sciences, Inc.
733 Bolsana Dr.
Laguna Beach,  CA  92651
Correspondent Contact JUDY F GORDON D.V.M.
Regulation Number880.5725
Classification Product Code
MRH  
Date Received08/09/2013
Decision Date 10/22/2013
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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