ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG— 510(k) K944378

Name: FDA 510(k) clearance K944378
Creator: U.S. Food and Drug Administration
Published: 1995-02-15

Substantially Equivalent

Regulatory & Marketing Services, Inc.

FDA 510(k) clearance K944378 for ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG, Substantially Equivalent on 1995-02-15. Applicant: Regulatory & Marketing Services, Inc.. Device class: 1.

Clearance details

Applicant: Regulatory & Marketing Services, Inc.
Product code: Code FGM
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-07
Decision date: 1995-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, US

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