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FDA 510(k)

CESIUM 137 SOURCE, MODEL CSM-40

K-Number: K882449 · 1989-04-14

ApplicantCis-Us, Inc.
Decision Date1989-04-14
Product CodeIWI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CESIUM 137 SOURCE, MODEL CSM-40 is the device name listed in this FDA 510(k) record. The listed applicant is Cis-Us, Inc.. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K882449. The device is classified under product code IWI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CESIUM 137 SOURCE, MODEL CSM-40?

CESIUM 137 SOURCE, MODEL CSM-40 is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Cis-Us, Inc.. The 510(k) number is K882449.

When did CESIUM 137 SOURCE, MODEL CSM-40 receive FDA 510(k) clearance?

CESIUM 137 SOURCE, MODEL CSM-40 received FDA 510(k) clearance on 1989-04-14, under 510(k) number K882449.

Who is the listed applicant for CESIUM 137 SOURCE, MODEL CSM-40?

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

What is the FDA product code for CESIUM 137 SOURCE, MODEL CSM-40?

The FDA product code for CESIUM 137 SOURCE, MODEL CSM-40 is IWI.

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 Cis-Us, 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.

K951708ELSA-HCTK950211ELSA-PTHK890799CURIETRON 192 HIGH DOSE RATEK871502PERSONNEL PROTECTIVE SHIELDK865027IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137CK863778VENTICIS II

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Related Devices (Code: IWI)

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.

K973363NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633Ml Strategies, Inc.K940632I-125 RAPID STRANDMedi-Physics Inc. Dba Nycomed Amersham ImagingK912170RADIOACTIVE IODINE-125 SOURCESBest IndustriesK874787MODIFIED PALLADIUM SEED MODEL 100Theragenics Corp.K852542PALLADIUM SEED MODEL 100Nuclear Medicine, 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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