INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A— 510(k) K853171

Name: FDA 510(k) clearance K853171
Creator: U.S. Food and Drug Administration
Published: 1985-10-01

Substantially Equivalent for Some Indications

Int'L Hearing Aids, Inc.

FDA 510(k) clearance K853171 for INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A, Substantially Equivalent for Some Indications on 1985-10-01. Applicant: Int'L Hearing Aids, Inc.. Device class: 1.

Clearance details

Applicant: Int'L Hearing Aids, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1985-07-30
Decision date: 1985-10-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

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