EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)— 510(k) K041702

Name: FDA 510(k) clearance K041702
Creator: U.S. Food and Drug Administration
Published: 2004-07-16

Substantially Equivalent

Ibt SA

FDA 510(k) clearance K041702 for EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.), Substantially Equivalent on 2004-07-16. Applicant: Ibt SA. Device class: 2.

Clearance details

Applicant: Ibt SA
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2004-06-22
Decision date: 2004-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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