MODEL 3000C CALORIC IRRIGATOR— 510(k) K813552

Name: FDA 510(k) clearance K813552
Creator: U.S. Food and Drug Administration
Published: 1982-02-22

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K813552 for MODEL 3000C CALORIC IRRIGATOR, Substantially Equivalent on 1982-02-22. Applicant: Life-Tech Intl., Inc.. Device class: 1.

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code ETP
Device class: Class 1
Regulation: 21 CFR 874.1800
Advisory panel: Ear, Nose, Throat
Date received: 1981-12-21
Decision date: 1982-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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