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FDA 510(k)

BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER

K-Number: K043117 · 2004-12-09

ApplicantBest Medical International, Inc.
Decision Date2004-12-09
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER 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 2004-12-09 under 510(k) number K043117. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER?

BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER is a medical device that received FDA 510(k) clearance on 2004-12-09. The listed applicant is Best Medical International, Inc.. The 510(k) number is K043117.

When did BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER receive FDA 510(k) clearance?

BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER received FDA 510(k) clearance on 2004-12-09, under 510(k) number K043117.

Who is the listed applicant for BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER?

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 RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER?

The FDA product code for BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER is KXK.

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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 SPACERK042786BEST MODEL # 81-01 SERIES IR-192 SOURCESK042586BEST BREAST BRACHYTHERAPY APPLICATOR

Related Devices (Code: KXK)

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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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