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FDA 510(k)

IR-192 IMPLANT

K-Number: K903465 · 1990-10-12

ApplicantRads S.L., Inc.
Decision Date1990-10-12
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IR-192 IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Rads S.L., Inc.. It received FDA 510(k) clearance on 1990-10-12 under 510(k) number K903465. 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 IR-192 IMPLANT?

IR-192 IMPLANT is a medical device that received FDA 510(k) clearance on 1990-10-12. The listed applicant is Rads S.L., Inc.. The 510(k) number is K903465.

When did IR-192 IMPLANT receive FDA 510(k) clearance?

IR-192 IMPLANT received FDA 510(k) clearance on 1990-10-12, under 510(k) number K903465.

Who is the listed applicant for IR-192 IMPLANT?

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

What is the FDA product code for IR-192 IMPLANT?

The FDA product code for IR-192 IMPLANT is KXK.

Related Clinical Trials

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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Other records listing Rads S.L., Inc. as applicant

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.

K874895IR-192 IMPLANTK844248IR-192 IMPLANT

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

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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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