Cleared Traditional

K832804 - SESAM TABLE
(FDA 510(k) Clearance)

Sep 1983
Decision
33d
Days
Class 1
Risk

K832804 is an FDA 510(k) clearance for the SESAM TABLE. This device is classified as a Table, Powered (Class I - General Controls, product code INQ).

Submitted by Electro-Med Health Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983, 33 days after receiving the submission on August 18, 1983.

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

Submission Details

510(k) Number K832804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date September 20, 1983
Days to Decision 33 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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