Cleared Traditional

K830855 - SESAM TREATMENT TABLE
(FDA 510(k) Clearance)

Apr 1983
Decision
19d
Days
Class 1
Risk

K830855 is an FDA 510(k) clearance for the SESAM TREATMENT TABLE. This device is classified as a Table, Powered (Class I - General Controls, product code INQ).

Submitted by Lic-Orthion (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983, 19 days after receiving the submission on March 17, 1983.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3760.

Submission Details

510(k) Number K830855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1983
Decision Date April 05, 1983
Days to Decision 19 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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