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FDA 510(k)

Ontex and other proprietary names

K-Number: K162746 · 2017-03-03

ApplicantOntex Bvba
Decision Date2017-03-03
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Ontex and other proprietary names is a medical device manufactured by Ontex Bvba. It received FDA 510(k) clearance on 2017-03-03 under approval number K162746. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ontex and other proprietary names?

Ontex and other proprietary names is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Ontex Bvba. The 510(k) number is K162746.

When was Ontex and other proprietary names approved by the FDA?

Ontex and other proprietary names received FDA 510(k) clearance on 2017-03-03, under approval number K162746.

What company makes Ontex and other proprietary names?

Ontex and other proprietary names is manufactured by Ontex Bvba.

What is the FDA product code for Ontex and other proprietary names?

The FDA product code for Ontex and other proprietary names is HEB.

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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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