CATHEJELL S STERILE LUBRICATING JELLY— 510(k) K935548

Name: FDA 510(k) clearance K935548
Creator: U.S. Food and Drug Administration
Published: 1994-03-30

Substantially Equivalent

Pharmazeutische Fabrik Montavit GmbH

FDA 510(k) clearance K935548 for CATHEJELL S STERILE LUBRICATING JELLY, Substantially Equivalent on 1994-03-30. Applicant: Pharmazeutische Fabrik Montavit GmbH. Device class: 2.

Clearance details

Applicant: Pharmazeutische Fabrik Montavit GmbH
Product code: Code FHX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-11-17
Decision date: 1994-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilton, CT, 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.