PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER— 510(k) K952414

Name: FDA 510(k) clearance K952414
Creator: U.S. Food and Drug Administration
Published: 1995-06-23

Substantially Equivalent

Acacia Laboratories, Inc.

FDA 510(k) clearance K952414 for PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER, Substantially Equivalent on 1995-06-23. Applicant: Acacia Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Acacia Laboratories, Inc.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1995-05-23
Decision date: 1995-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, 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.