FDA 510(k) Applications for Medical Device Product Code "KYG"
(Device, Irrigation, Ocular Surgery)

FDA 510(k) Number Applicant Device Name Decision Date
K981116 ALLERGAN, INC. SOVEREIGN CATARACT EXTRACTION SYSTEM 05/19/1998
K974561 AMERICAN MEDICAL DEVICES, INC. MOISTAIR FLUID AIR TUBING SET 02/19/1998
K993591 BLADE WORKS, INC. BLADEWORKS DISPOSABLE ALK TUBING 12/28/1999
K954842 DUTCH OPHTHALMIC USA, INC. D.O.R.C. VFI/VFE SYSTEM 04/15/1996
K980647 EYE-DEAL OCULAR SAFETY PRODUCTS, INC. EYE IRRIGATOR MODEL #2020 05/15/1998
K970161 HEDGES CWP, INC. HEDGES CORNEAL WETTING PAK 03/25/1997
K010353 MED-LOGICS, INC. MED-LOGICS DISPOSABLE ALK TUBING 04/27/2001
K971173 MED-LOGICS, INC. ML DISPOSABLE ALK TUBING 05/22/1997
K003036 RETINALABS.COM TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 12/22/2000


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