UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS— 510(k) K864277

Name: FDA 510(k) clearance K864277
Creator: U.S. Food and Drug Administration
Published: 1987-01-09

Substantially Equivalent

Unimax Hearing Instruments

FDA 510(k) clearance K864277 for UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS, Substantially Equivalent on 1987-01-09. Applicant: Unimax Hearing Instruments. Device class: 1.

Clearance details

Applicant: Unimax Hearing Instruments
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1986-10-30
Decision date: 1987-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denton, TX, US

Download summary PDF View on FDA.gov ↗

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