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FDA 510(k)

RADIOACTIVE IODINE-125 SOURCES

K-Number: K912170 · 1991-08-09

ApplicantBest Industries
Decision Date1991-08-09
Product CodeIWI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOACTIVE IODINE-125 SOURCES is the device name listed in this FDA 510(k) record. The listed applicant is Best Industries. It received FDA 510(k) clearance on 1991-08-09 under 510(k) number K912170. 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 RADIOACTIVE IODINE-125 SOURCES?

RADIOACTIVE IODINE-125 SOURCES is a medical device that received FDA 510(k) clearance on 1991-08-09. The listed applicant is Best Industries. The 510(k) number is K912170.

When did RADIOACTIVE IODINE-125 SOURCES receive FDA 510(k) clearance?

RADIOACTIVE IODINE-125 SOURCES received FDA 510(k) clearance on 1991-08-09, under 510(k) number K912170.

Who is the listed applicant for RADIOACTIVE IODINE-125 SOURCES?

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

What is the FDA product code for RADIOACTIVE IODINE-125 SOURCES?

The FDA product code for RADIOACTIVE IODINE-125 SOURCES is IWI.

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Other records listing Best Industries 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.

K940121IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERSK940119ROYAL MARSDEN GOLD GRAIN GUNK933410IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCESK932242RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345K930570RADIOACTIVE PALLADIUM 103 SEEDS/SOURCESK924290BEST INDUSTRIES CARTRIDGE & GUN

View all 9 devices →

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 ImagingK882449CESIUM 137 SOURCE, MODEL CSM-40Cis-Us, Inc.K874787MODIFIED 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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