ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR— 510(k) K882721

Name: FDA 510(k) clearance K882721
Creator: U.S. Food and Drug Administration
Published: 1988-09-15

Substantially Equivalent

Hear-O Inc. C/O L.P. Leale & Assoc.

FDA 510(k) clearance K882721 for ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR, Substantially Equivalent on 1988-09-15. Applicant: Hear-O Inc. C/O L.P. Leale & Assoc.. Device class: 1.

Clearance details

Applicant: Hear-O Inc. C/O L.P. Leale & Assoc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1988-07-01
Decision date: 1988-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

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