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FDA 510(k)

ONCOBIONIC SYSTEM

K-Number: K080376 · 2008-04-02

ApplicantOncobionic Incorporated
Decision Date2008-04-02
Product CodeOAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ONCOBIONIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oncobionic Incorporated. It received FDA 510(k) clearance on 2008-04-02 under 510(k) number K080376. The device is classified under product code OAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONCOBIONIC SYSTEM?

ONCOBIONIC SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-02. The listed applicant is Oncobionic Incorporated. The 510(k) number is K080376.

When did ONCOBIONIC SYSTEM receive FDA 510(k) clearance?

ONCOBIONIC SYSTEM received FDA 510(k) clearance on 2008-04-02, under 510(k) number K080376.

Who is the listed applicant for ONCOBIONIC SYSTEM?

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

What is the FDA product code for ONCOBIONIC SYSTEM?

The FDA product code for ONCOBIONIC SYSTEM is OAB.

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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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