URINARY DRAINAGE BAG— 510(k) K934080

Substantially Equivalent

Kit Pak, Inc.

FDA 510(k) clearance K934080 for URINARY DRAINAGE BAG, Substantially Equivalent on 1994-05-18. Applicant: Kit Pak, Inc.. Device class: 1.

Clearance details

Applicant: Kit Pak, Inc.
Product code: Code EYT
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1993-08-20
Decision date: 1994-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.