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FDA 510(k)

BEST BREAST BRACHYTHERAPY APPLICATOR

K-Number: K042586 · 2004-11-03

ApplicantBest Medical International, Inc.
Decision Date2004-11-03
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BEST BREAST BRACHYTHERAPY APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Best Medical International, Inc.. It received FDA 510(k) clearance on 2004-11-03 under 510(k) number K042586. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEST BREAST BRACHYTHERAPY APPLICATOR?

BEST BREAST BRACHYTHERAPY APPLICATOR is a medical device that received FDA 510(k) clearance on 2004-11-03. The listed applicant is Best Medical International, Inc.. The 510(k) number is K042586.

When did BEST BREAST BRACHYTHERAPY APPLICATOR receive FDA 510(k) clearance?

BEST BREAST BRACHYTHERAPY APPLICATOR received FDA 510(k) clearance on 2004-11-03, under 510(k) number K042586.

Who is the listed applicant for BEST BREAST BRACHYTHERAPY APPLICATOR?

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

What is the FDA product code for BEST BREAST BRACHYTHERAPY APPLICATOR?

The FDA product code for BEST BREAST BRACHYTHERAPY APPLICATOR is JAQ.

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Other records listing Best Medical International, 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.

K162499Best Instruminal ApplicatorK132097BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPYK061638BEST STRAND AND BEST SPACERK043117BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKERK042786BEST MODEL # 81-01 SERIES IR-192 SOURCES

Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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