CPR URETHRAL CATHETER TRAY— 510(k) K960215

Name: FDA 510(k) clearance K960215
Creator: U.S. Food and Drug Administration
Published: 1996-04-01

Substantially Equivalent

Custom Pack Reliability

FDA 510(k) clearance K960215 for CPR URETHRAL CATHETER TRAY, Substantially Equivalent on 1996-04-01. Applicant: Custom Pack Reliability. Device class: 2.

Clearance details

Applicant: Custom Pack Reliability
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1996-01-16
Decision date: 1996-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.