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Establishment Registration & Device Listing

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Product Code : HQL

Establishment
Name

Registration Number

Current
Registration Yr

ELLIS OPHTHALMIC TECHNOLOGIES, INC

NY/USA

2438659

2013

intraocular lens

U.S. Manufacturer of Export Only Devices

EYEKON MEDICAL, INC.

FL/USA

1038833

2013

intraocular lens - Acuity; Acurus; Cirrus; DGR; EyeKon; Isotechnics; MDR; MTH; Suncoast

Contract Manufacturer; Manufacturer

intraocular lens - Acuity; Acurus; Cirrus; DGR; EyeKon; Isotechnics; MDR; MTH; Suncoast

U.S. Manufacturer of Export Only Devices

FOOD TECHNOLOGY SERVICE, INC.

FL/USA

1054811

2013

intraocular lens

Contract Sterilizer

HOYA MEDICAL SINGAPORE PTE LTD

SINGAPORE

3007125265

2013

intraocular lens - iSert Preloaded IOL System (Model No. 231); iSert Preloaded IOL System (Model PC-60AD); iSert Preloaded IOL System (Model PY-60AD); iSert Preloaded IOL System (Model PY-60R); iSpheric IOL (Model YA-60BB); iSpheric IOL (Model YA-60BBR); iSymm IOL (Model FC-60AD); iSymm IOL (Model FY-60AD)

Contract Manufacturer; Contract Sterilizer; Manufacturer

HOYA SURGICAL OPTICS, INC.

CA/USA

3006723646

2013

intraocular lens - iSert Preloaded IOL System (Model No. 230); iSert Preloaded IOL System (Model No. 231); iSert Preloaded IOL System (Model PC-60AD); iSert Preloaded IOL System (Model PY-60AD); iSert Preloaded IOL System (Model PY-60R); iSpheric IOL (Model YA-60BB); iSpheric IOL (Model YA-60BBR); iSymm IOL (Model FC-60AD); iSymm IOL (Model FY-60AD)

Repackager/Relabeler

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