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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 DRIVE
LAGUNA BEACH,  CA  92651
Applicant Contact JUDY F GORDON D.V.M.
Correspondent
SIGHT SCIENCES, INC.
733 BOLSANA DRIVE
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
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