NAVARRE 600 ML DRAINAGE BAG— 510(k) K943663

Name: FDA 510(k) clearance K943663
Creator: U.S. Food and Drug Administration
Published: 1994-09-08

Substantially Equivalent

Navarre Biomedical , Ltd.

FDA 510(k) clearance K943663 for NAVARRE 600 ML DRAINAGE BAG, Substantially Equivalent on 1994-09-08. Applicant: Navarre Biomedical , Ltd.. Device class: 2.

Clearance details

Applicant: Navarre Biomedical , Ltd.
Product code: Code EXF
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 1994-07-28
Decision date: 1994-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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.