GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT— 510(k) K070048

Name: FDA 510(k) clearance K070048
Creator: U.S. Food and Drug Administration
Published: 2007-03-15

Substantially Equivalent

Marian Medical, Inc.

FDA 510(k) clearance K070048 for GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT, Substantially Equivalent on 2007-03-15. Applicant: Marian Medical, Inc.. Device class: 2.

Clearance details

Applicant: Marian Medical, Inc.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2007-01-03
Decision date: 2007-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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