URETHRAL CATHETERIZATION TRAY— 510(k) K950390

Name: FDA 510(k) clearance K950390
Creator: U.S. Food and Drug Administration
Published: 1995-05-30

Substantially Equivalent

Medcare Custom Packaging, Inc.

FDA 510(k) clearance K950390 for URETHRAL CATHETERIZATION TRAY, Substantially Equivalent on 1995-05-30. Applicant: Medcare Custom Packaging, Inc.. Device class: 2.

Clearance details

Applicant: Medcare Custom Packaging, Inc.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1995-02-01
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Swanzey, NH, US

Download summary PDF View on FDA.gov ↗

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