i-Promotions Contact Lens Case (K042578) i-Promotions Inc. / Dow Chemical / K1 12832 Trade / Dow Chemical Company / Contact Lens Case (K030987) Pelican Products Inc. / Promotions Contact Lens Case K042578 Pelican Products Inc. / Cure Corporation / / /
Event
FDA Phase / /
IndustryTerm
non implanted medical device / gas permeable / predicate device / heat disinfection devices / manufacturing practice requirements / chemical disinfection / manufacturing practice / non-sterile device / Internet address http /
MedicalCondition
MS / Delayed-Type Hypersensitivity / Irritation / /
Organization
Device Evaluation Center / Division of Postmarket Surveillance / Food and Drug Administration / office of Compliance / office of Device Evaluation / Ear / Nose and Throat Devices Office / Division of Ophthalmic / Neurological and Ear / Center for Devices and Radiological Health / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Ophthalmic / CDRH's office of Surveillance / /
Person
Lindy van Dalen / Eye Care / Malvina B. Eydelman / Silver Spring / / /
K//I 510(k) Summary 1. Date of Preparation: September 21, [removed]Applicant Device Information: Device Name: Eye Care and Cure Contact Lens Case