UROLAB SPECTRUM— 510(k) K931179

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K931179 for UROLAB SPECTRUM, Substantially Equivalent on 1993-11-18. 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: 1993-03-09
Decision date: 1993-11-18
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.