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FDA 510(k)

OSTAR

K-Number: K955424 · 1996-06-10

ApplicantUltravena Industries, Ltd.
Decision Date1996-06-10
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OSTAR is the device name listed in this FDA 510(k) record. The listed applicant is Ultravena Industries, Ltd.. It received FDA 510(k) clearance on 1996-06-10 under 510(k) number K955424. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTAR?

OSTAR is a medical device that received FDA 510(k) clearance on 1996-06-10. The listed applicant is Ultravena Industries, Ltd.. The 510(k) number is K955424.

When did OSTAR receive FDA 510(k) clearance?

OSTAR received FDA 510(k) clearance on 1996-06-10, under 510(k) number K955424.

Who is the listed applicant for OSTAR?

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

What is the FDA product code for OSTAR?

The FDA product code for OSTAR is LYY.

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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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