Cleared Traditional

K AND D HOME TRACT

K872121 · Joseph A. Kott, M.D. · Neurology
Aug 1987
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K872121 is an FDA 510(k) clearance for the K AND D HOME TRACT, a Apparatus, Traction, Non-powered (Class I — General Controls, product code HST), submitted by Joseph A. Kott, M.D. (Metairie, US). The FDA issued a Cleared decision on August 12, 1987, 77 days after receiving the submission on May 27, 1987. This device falls under the Neurology review panel. Regulated under 21 CFR 888.5850.

Submission Details

510(k) Number K872121 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1987
Decision Date August 12, 1987
Days to Decision 77 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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