ORTHO CONTROL FEMALE URINARY CONTROL DEVICE— 510(k) K010365

Name: FDA 510(k) clearance K010365
Creator: U.S. Food and Drug Administration
Published: 2001-04-30

Substantially Equivalent

Personal Products Co.

FDA 510(k) clearance K010365 for ORTHO CONTROL FEMALE URINARY CONTROL DEVICE, Substantially Equivalent on 2001-04-30. Applicant: Personal Products Co.. Device class: 1.

Clearance details

Applicant: Personal Products Co.
Product code: Code MNG
Device class: Class 1
Regulation: 21 CFR 876.5160
Advisory panel: Gastroenterology, Urology
Date received: 2001-02-07
Decision date: 2001-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, NJ, US

Download summary PDF View on FDA.gov ↗

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