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FDA 510(k)

NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633

K-Number: K973363 · 1998-07-02

ApplicantMl Strategies, Inc.
Decision Date1998-07-02
Product CodeIWI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 is the device name listed in this FDA 510(k) record. The listed applicant is Ml Strategies, Inc.. It received FDA 510(k) clearance on 1998-07-02 under 510(k) number K973363. 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 NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633?

NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 is a medical device that received FDA 510(k) clearance on 1998-07-02. The listed applicant is Ml Strategies, Inc.. The 510(k) number is K973363.

When did NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 receive FDA 510(k) clearance?

NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 received FDA 510(k) clearance on 1998-07-02, under 510(k) number K973363.

Who is the listed applicant for NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633?

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

What is the FDA product code for NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633?

The FDA product code for NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 is IWI.

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Other records listing Ml Strategies, 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.

K983401FRAMEWAVE WEBK972271NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-AK950354HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY

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.

K940632I-125 RAPID STRANDMedi-Physics Inc. Dba Nycomed Amersham ImagingK912170RADIOACTIVE IODINE-125 SOURCESBest IndustriesK882449CESIUM 137 SOURCE, MODEL CSM-40Cis-Us, Inc.K874787MODIFIED PALLADIUM SEED MODEL 100Theragenics Corp.K852542PALLADIUM SEED MODEL 100Nuclear Medicine, Inc.

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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