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Vision / Optometry / Geometrical optics / Contact lenses / Myopia / Presbyopia / Astigmatism / Refractive error / Lens / Optics / Corrective lenses / Ophthalmology


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2015-01-14 16:52:59

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City

Rosa Beach / /

Company

Johnson & Johnson / K120228 Pegavision Corporation / Traditional 510(k) Pegavision Corporation / Pegavision Corporation / 6 Pegavision Corporation / K140025 Trade / 3 Pegavision Corporation / /

Country

Taiwan / /

/

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

saline solution / announcements concerning your device / predicate devices / manufacturing practice requirements / normal buffered saline solution / marketed predicate devices / manufacturing practice / Internet address http /

MedicalCondition

astigmatism / myopia / ocular irritation / sealed blister / presbyopia / ametropia / hyperopia / /

NaturalFeature

Deborah L. Falls / /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Device Evaluation Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved / Division of Ophthalmic and Ear / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Division of Ophthalmic / CDRH’s office of Surveillance / Ear / Nose and Throat Devices Office / /

Person

Penny Northcutt / Shing Yeh St. Shan / Malvina B. Eydelman / Ding Vil Kwei Shan Hsiang / Tony Hsu / Silver Spring / /

/

Position

President / Director / OFFICIAL CORRESPONDENT / M.D. Director / /

Product

K140025 K962804 Vistakon / Johnson & Johnson Vision Products / K140025 Historical Clinical / Federal Food / K140025 K962804 Vistakon / /

ProgrammingLanguage

FL / /

ProvinceOrState

Florida / /

Technology

radiation / polymerization / /

URL

http /

SocialTag