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FDA 510(k)

CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.

K-Number: K800320 · 1980-03-25

ApplicantAmersham Corp.
Decision Date1980-03-25
Product CodeIWJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800320. The device is classified under product code IWJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.?

CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Amersham Corp.. The 510(k) number is K800320.

When did CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. receive FDA 510(k) clearance?

CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800320.

Who is the listed applicant for CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.?

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

What is the FDA product code for CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.?

The FDA product code for CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. is IWJ.

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Other records listing Amersham Corp. 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.

K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

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Related Devices (Code: IWJ)

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.

K010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMImagyn Medical Technologies, Inc.K980997PGK DEVICE (MODIFIED)Pgk, Inc.K972554REGANES RADIONUCLIDE SEED MAGAZINEAvid N.I.T., Inc.K973037N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000Avid N.I.T., Inc.K974118WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SETWorldwide Medical Technologies, LLCK973786NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDENw Radiation Therapy Products

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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