1351 UROFLOW AUTO START— 510(k) K853936

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K853936 for 1351 UROFLOW AUTO START, Substantially Equivalent on 1985-12-02. Applicant: Life-Tech Intl., Inc.. Device class: 2.

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1985-09-24
Decision date: 1985-12-02
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.