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FDA 510(k)

10 CURIE IRDIUM 192, CSN00100-192

K-Number: K991571 · 2000-02-22

ApplicantAlpha-Omega Services, Inc.
Decision Date2000-02-22
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

10 CURIE IRDIUM 192, CSN00100-192 is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Omega Services, Inc.. It received FDA 510(k) clearance on 2000-02-22 under 510(k) number K991571. 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 10 CURIE IRDIUM 192, CSN00100-192?

10 CURIE IRDIUM 192, CSN00100-192 is a medical device that received FDA 510(k) clearance on 2000-02-22. The listed applicant is Alpha-Omega Services, Inc.. The 510(k) number is K991571.

When did 10 CURIE IRDIUM 192, CSN00100-192 receive FDA 510(k) clearance?

10 CURIE IRDIUM 192, CSN00100-192 received FDA 510(k) clearance on 2000-02-22, under 510(k) number K991571.

Who is the listed applicant for 10 CURIE IRDIUM 192, CSN00100-192?

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

What is the FDA product code for 10 CURIE IRDIUM 192, CSN00100-192?

The FDA product code for 10 CURIE IRDIUM 192, CSN00100-192 is KXK.

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Other records listing Alpha-Omega Services, Inc. as applicant

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K233628AOS Interstitial Templates, Needles, and AccessoriesK233626AOS Marker Seeds (SMG0242-025)K102811AOS ORION IR-192 SOURCE CABLEK062824AOS UNIVERSAL CONECTING GUIDE TUBEK062823AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIESK062825AOS MARKER SEEDS

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Related Devices (Code: KXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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