HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER— 510(k) K950344

Name: FDA 510(k) clearance K950344
Creator: U.S. Food and Drug Administration
Published: 1995-03-24

Unknown

Acacia Laboratories, Inc.

FDA 510(k) clearance K950344 for HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER, Unknown on 1995-03-24. Applicant: Acacia Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Acacia Laboratories, Inc.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1995-01-27
Decision date: 1995-03-24
Decision: Unknown
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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