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FDA 510(k)

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source

K-Number: K162573 · 2016-11-04

ApplicantSource Production and Equipment Co., Inc.
Decision Date2016-11-04
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is a medical device manufactured by Source Production and Equipment Co., Inc.. It received FDA 510(k) clearance on 2016-11-04 under approval number K162573. 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 Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Source Production and Equipment Co., Inc.. The 510(k) number is K162573.

When was Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source approved by the FDA?

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source received FDA 510(k) clearance on 2016-11-04, under approval number K162573.

What company makes Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is manufactured by Source Production and Equipment Co., Inc..

What is the FDA product code for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

The FDA product code for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is KXK.

Related Clinical Trials

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Other Devices by Source Production and Equipment Co., Inc.

K161396SPEC Model M23 K161395SPEC Model M13

Related Devices (Code: KXK)

K163206SMD-Sr90-DA Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc. K161396SPEC Model M23Source Production and Equipment Co., Inc. K161395SPEC Model M13Source Production and Equipment Co., Inc. K171487Sirius MRI Marker NSC4 Imaging, LLC K163572LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceLv Liberty Vision Corp. K180515GammaTileIsoray Medical, Inc.

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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