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Medical equipment / Food law / Medical technology / Prosthetics / Congenital lacrimal duct obstruction / Medical device / Federal Food / Drug / and Cosmetic Act / Premarket approval / Nasolacrimal duct / Medicine / Health / Food and Drug Administration


5 10(k) Summary MASTERKAO Stent (FCI) Page 1 of[removed]k) Summary as required by 21 CFR§[removed]c)
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Document Date: 2012-09-10 10:26:01

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File Size: 225,41 KB

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City

Cincinnati / /

Company

FCJ Ophthalmics Inc. / K1 13536 Trade / D. Clinical Research Consultants Inc. / FCI Ophthalmics Inc / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

metal-to-metal contact / announcements concerning your device / predicate devices / stainless steel introducer / manufacturing practice requirements / proper intubation device / nasolacrimal intubation devices / marketed predicate devices / Internet address http /

MedicalCondition

epiphora and mucous discharge / congenital lacrimal duct obstructions / keratitis / postoperative epistaxis / /

Organization

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

Person

Barbara S. Fant / Silver Spring / B. Eydelman / /

/

Position

fixation head / anchoring fixation head for each implanted MASTERKAV device / Director f / General / /

Product

Mono-Crawford Naso-Lascrimal Intubation Device / K06 / K061404 / /

ProvinceOrState

Maryland / Ohio / /

Technology

radiation / /

URL

http /

SocialTag