URO-FLO— 510(k) K945140

Substantially Equivalent

Mallinckrodt Group, Inc.

FDA 510(k) clearance K945140 for URO-FLO, Substantially Equivalent on 1995-03-08. Applicant: Mallinckrodt Group, Inc.. Device class: 2.

Clearance details

Applicant: Mallinckrodt Group, Inc.
Product code: Code LJH
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1994-10-20
Decision date: 1995-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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