EAR-A-GATOR— 510(k) K946108

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K946108 for EAR-A-GATOR, Substantially Equivalent on 1995-06-13. Applicant: Life-Tech Intl., Inc.. Device class: 1.

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code KHH
Device class: Class 1
Regulation: 21 CFR 874.1800
Advisory panel: Ear, Nose, Throat
Date received: 1994-12-14
Decision date: 1995-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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