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K13 1875 Page I of 4 Menicon Nect Co., Ltd. 510(k) Summary MENICON NIECT
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Document Date: 2013-09-13 12:40:50

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City

Wilmington / /

Company

4 K131875 Menicon Nect Co. Ltd. / K13 1875 Menicon Nect Co. Ltd. / Sacks Holdings Inc. / Menicon Nect Co. Ltd. / K 121030 Sacks Holdings Inc. / 4 Menicon Nect Co. Ltd. / Characteristics Menicon Nect Co. Ltd. / K121030 Sacks Holdings Inc. / K1 31875 Trade / Applicant Information Menicon Nect Co. Ltd / Case 510(k) Menicon Nect Co. Ltd. / /

Event

FDA Phase / /

IndustryTerm

Internet address http /

MarketIndex

Case 510 / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / office of Device Evaluation / Division of Ophdmalmic / Device Evaluation Center for Devices / Division of Ophdmalmic and Ear / Division of Small Manufacturers / International and Consumer Assistance / Division of Ophthalmic and Ear / CDRH's office of Surveillance / Ear / Nose and Throat Devices Office / /

Person

Jeffrey M.Brocious / Kesia Y.Alexander / Ellen Heucler / Shinji Tanaka / Malvina B. Eydelman / /

/

Position

Vice President Foresight Regulatory Strategies / Director / FBeueler Vice President / /

Product

Federal Food / 2I1CFR / 2Q13 / /

ProvinceOrState

Massachusetts / /

Technology

radiation / http / /

URL

http /

SocialTag