Cleared Traditional

TRACTION ACCESSORIES

K830244 · Warm & Form, Orthopedic Materials · Neurology
Mar 1983
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K830244 is an FDA 510(k) clearance for the TRACTION ACCESSORIES, a Apparatus, Traction, Non-powered (Class I — General Controls, product code HST), submitted by Warm & Form, Orthopedic Materials (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983, 43 days after receiving the submission on January 25, 1983. This device falls under the Neurology review panel. Regulated under 21 CFR 888.5850.

Submission Details

510(k) Number K830244 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1983
Decision Date March 09, 1983
Days to Decision 43 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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