Cleared Traditional

TECHNA VISION CASTING RESIN

K862578 · Techna Vision · Ophthalmic
Jul 1986
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K862578 is an FDA 510(k) clearance for the TECHNA VISION CASTING RESIN, a Lens, Spectacle, Non-custom (prescription) (Class I — General Controls, product code HQG), submitted by Techna Vision (Santee, US). The FDA issued a Cleared decision on July 23, 1986, 16 days after receiving the submission on July 7, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5844.

Submission Details

510(k) Number K862578 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1986
Decision Date July 23, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQG — Lens, Spectacle, Non-custom (prescription)
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.5844

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