Cleared Traditional

EXTENSIONS-LUSATZTISCH

K812779 · The Telos Co. · Neurology
Oct 1981
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K812779 is an FDA 510(k) clearance for the EXTENSIONS-LUSATZTISCH, a Apparatus, Traction, Non-powered (Class I — General Controls, product code HST), submitted by The Telos Co. (Walker, US). The FDA issued a Cleared decision on October 26, 1981, 21 days after receiving the submission on October 5, 1981. This device falls under the Neurology review panel. Regulated under 21 CFR 888.5850.

Submission Details

510(k) Number K812779 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1981
Decision Date October 26, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary

Device Classification

Product Code HST — Apparatus, Traction, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.5850

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