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Distometer Suppliers

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Western Ophthalmics Corporation | Address: 19019 36th Ave W, Suite G, Lynnwood, Washington 98036, USA USA
www.west-op.com | Send Inquiry | Phone: +1-(425)-672-9332, 800-426-9938
Year Established: 1998  Annual Revenues: < USD 1 Million
Products: Batteries, Eye Protection, Bulbs, Eye Bubble, Disometers, Auto Lensometer, ...
Western Ophthalmics Corporation specializes in opthalmic instruments and supplies. Our product list comprises of ophthalmic batteries, ophthalmic bulbs, eye patches, printer papers, and occlusion foil more...
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 EMAIL INQUIRY to  1 Distometer suppliers  
FDA Code / Regulation: HMM / 886.1190

A distometer is a device intended to measure the distance between the cornea and a corrective lens during refraction to help measure the change of the visual image when a lens is in place.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

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