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FDA 510(k)

OSSIX -PLUS

K-Number: K053260 · 2006-02-22

ApplicantColbar Lifescience , Ltd.
Decision Date2006-02-22
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSIX -PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Colbar Lifescience , Ltd.. It received FDA 510(k) clearance on 2006-02-22 under 510(k) number K053260. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSIX -PLUS?

OSSIX -PLUS is a medical device that received FDA 510(k) clearance on 2006-02-22. The listed applicant is Colbar Lifescience , Ltd.. The 510(k) number is K053260.

When did OSSIX -PLUS receive FDA 510(k) clearance?

OSSIX -PLUS received FDA 510(k) clearance on 2006-02-22, under 510(k) number K053260.

Who is the listed applicant for OSSIX -PLUS?

The FDA 510(k) record lists Colbar Lifescience , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSIX -PLUS?

The FDA product code for OSSIX -PLUS is NPL.

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Official Source

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

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