QUIESCENCE— 510(k) K040330

Name: FDA 510(k) clearance K040330
Creator: U.S. Food and Drug Administration
Published: 2004-04-12

Substantially Equivalent

Spectral Visualization & Development, Inc.

FDA 510(k) clearance K040330 for QUIESCENCE, Substantially Equivalent on 2004-04-12. Applicant: Spectral Visualization & Development, Inc.. Device class: 2.

Clearance details

Applicant: Spectral Visualization & Development, Inc.
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2004-02-11
Decision date: 2004-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fredericton,New Brunswick, CA

Download summary PDF View on FDA.gov ↗

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