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Economy Line of Trays

by Abco Dealers, Inc.

510(k) K820589

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820589 Date9 Apr 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRG
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Economy Line of Trays is a disposable food tray designed for use in general hospital settings. These trays are intended for serving and transporting food, adhering to the product code FRG classification under the General Hospital device category.

Supplied as single-use items, these trays are cleared for use in healthcare environments under FDA 510(k) clearance (K820589). They are intended for one-time use and must be stored in a clean, dry environment prior to use, with no specific regulatory notes on MRI safety or sterility beyond standard disposable medical device practices.

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