ULTRAQUIET— 510(k) K021202

Substantially Equivalent

Sound Technique System, LLC

FDA 510(k) clearance K021202 for ULTRAQUIET, Substantially Equivalent on 2002-07-13. Applicant: Sound Technique System, LLC. Device class: 2.

Clearance details

Applicant: Sound Technique System, LLC
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2002-04-16
Decision date: 2002-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.