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FDA 510(k)

LAWRENCE CSERION, MODEL CS-1

K-Number: K030162 · 2003-03-28

ApplicantIsoray, Inc.
Decision Date2003-03-28
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LAWRENCE CSERION, MODEL CS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Isoray, Inc.. It received FDA 510(k) clearance on 2003-03-28 under 510(k) number K030162. 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 LAWRENCE CSERION, MODEL CS-1?

LAWRENCE CSERION, MODEL CS-1 is a medical device that received FDA 510(k) clearance on 2003-03-28. The listed applicant is Isoray, Inc.. The 510(k) number is K030162.

When did LAWRENCE CSERION, MODEL CS-1 receive FDA 510(k) clearance?

LAWRENCE CSERION, MODEL CS-1 received FDA 510(k) clearance on 2003-03-28, under 510(k) number K030162.

Who is the listed applicant for LAWRENCE CSERION, MODEL CS-1?

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

What is the FDA product code for LAWRENCE CSERION, MODEL CS-1?

The FDA product code for LAWRENCE CSERION, MODEL CS-1 is KXK.

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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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