Cleared Traditional

VECTOR BAR SUSPENSION/TRACTION UNIT

K852398 · Powlan Manufacturing Co. · Physical Medicine
Aug 1985
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K852398 is an FDA 510(k) clearance for the VECTOR BAR SUSPENSION/TRACTION UNIT, a Accessories, Traction (Class I — General Controls, product code ILZ), submitted by Powlan Manufacturing Co. (Lafayette, US). The FDA issued a Cleared decision on August 12, 1985, 67 days after receiving the submission on June 6, 1985. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5925.

Submission Details

510(k) Number K852398 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1985
Decision Date August 12, 1985
Days to Decision 67 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILZ — Accessories, Traction
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5925