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Splash Guard Goggle

by Dispomed, Inc. 510(k)

Active United States

510(k) K891052

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK891052 Date12 Apr 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FXX
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Splash Guard Goggle is a device that provides protection for the eyes. It is classified as a Mask, Surgical, and is used in the medical specialty of General and Plastic Surgery.

The Splash Guard Goggle is supplied with FDA 510K authorization, and has a product code of FXX. It is a Class 2 device, and was found to be Substantially Equivalent. The device has a K number of K891052, and was cleared on April 12, 1989.

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