Techna Vision Casting Resin

FDA 510(k) K862578 · Techna Vision

Substantially Equivalent

510(k) numberK862578

Submission

Device name
Techna Vision Casting Resin
Applicant
Techna Vision
Santee, CA, US
Received
July 7, 1986
Decision date
July 23, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HQG – Lens, Spectacle, Non-Custom (Prescription)
Device class
Class I (low risk)
Regulation
21 CFR 886.5844
Specialty
Ophthalmic

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K875063Seiko Plax Diacoat II & Seiko Plax S.V.P.HQG · Traditional Epson EL Paso, Inc.02/22/1988SE
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K873245Ar Diacoat Single Vision LensesHQG · Traditional Seiko Optical Products of America, Inc.10/05/1987SE

More from Seiko Optical Products of America, Inc.

510(k)DeviceDecision
K853290Techna Vision Auto-PerimeterHPT · Traditional 11/12/1985SE
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K853743Techna Vision, Inc. Electric ChairHME · Traditional 10/17/1985SE

Questions and answers

When was Techna Vision Casting Resin cleared by the FDA?

Techna Vision Casting Resin (K862578) received a 510(k) decision of Substantially Equivalent on July 23, 1986, 16 days after the submission was received.

What is the product code of K862578?

The FDA product code is HQG – Lens, Spectacle, Non-Custom (Prescription), a Class I (low risk) device regulated under 21 CFR 886.5844.