Cleared Traditional

SESAM TREATMENT TABLE

K823150 · Orthion Corp. · Physical Medicine
Nov 1982
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K823150 is an FDA 510(k) clearance for the SESAM TREATMENT TABLE, a Table, Powered (Class I — General Controls, product code INQ), submitted by Orthion Corp. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1982, 16 days after receiving the submission on October 20, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3760.

Submission Details

510(k) Number K823150 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1982
Decision Date November 05, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code INQ — Table, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3760

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