SUSTAINED PHONATION— 510(k) K962961

Name: FDA 510(k) clearance K962961
Creator: U.S. Food and Drug Administration
Published: 1996-09-09

Substantially Equivalent

Surface Mount Technology, Inc.

FDA 510(k) clearance K962961 for SUSTAINED PHONATION, Substantially Equivalent on 1996-09-09. Applicant: Surface Mount Technology, Inc.. Device class: 1.

Clearance details

Applicant: Surface Mount Technology, Inc.
Product code: Code KTH
Device class: Class 1
Regulation: 21 CFR 874.5840
Advisory panel: Ear, Nose, Throat
Date received: 1996-07-30
Decision date: 1996-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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