DR. DEDO'S FAMILY EAR EXAMINATION KIT— 510(k) K904659

Name: FDA 510(k) clearance K904659
Creator: U.S. Food and Drug Administration
Published: 1991-04-30

Substantially Equivalent

Panex Corp.

FDA 510(k) clearance K904659 for DR. DEDO'S FAMILY EAR EXAMINATION KIT, Substantially Equivalent on 1991-04-30. Applicant: Panex Corp.. Device class: 1.

Clearance details

Applicant: Panex Corp.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1990-10-15
Decision date: 1991-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Palm Beach, FL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.