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FDA 510(k)

EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)

K-Number: K041702 · 2004-07-16

ApplicantIbt SA
Decision Date2004-07-16
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) is the device name listed in this FDA 510(k) record. The listed applicant is Ibt SA. It received FDA 510(k) clearance on 2004-07-16 under 510(k) number K041702. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)?

EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) is a medical device that received FDA 510(k) clearance on 2004-07-16. The listed applicant is Ibt SA. The 510(k) number is K041702.

When did EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) receive FDA 510(k) clearance?

EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) received FDA 510(k) clearance on 2004-07-16, under 510(k) number K041702.

Who is the listed applicant for EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)?

The FDA 510(k) record lists Ibt SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)?

The FDA product code for EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.) is KXK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Ibt SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K043336OPTISTRAND, MODEL 1032S

Related Devices (Code: KXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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