HES ULTRASONIC THERAPY APPLIANCE— 510(k) K040798

Name: FDA 510(k) clearance K040798
Creator: U.S. Food and Drug Administration
Published: 2004-08-04

Substantially Equivalent

Hwang Sun Enterprise Co., Ltd.

FDA 510(k) clearance K040798 for HES ULTRASONIC THERAPY APPLIANCE, Substantially Equivalent on 2004-08-04. Applicant: Hwang Sun Enterprise Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hwang Sun Enterprise Co., Ltd.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2004-03-29
Decision date: 2004-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sound Beach, NY, US

Download summary PDF View on FDA.gov ↗

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