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FDA 510(k)

BEST STRAND AND BEST SPACER

K-Number: K061638 · 2006-08-04

ApplicantBest Medical International, Inc.
Decision Date2006-08-04
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BEST STRAND AND BEST SPACER 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 2006-08-04 under 510(k) number K061638. 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 STRAND AND BEST SPACER?

BEST STRAND AND BEST SPACER is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Best Medical International, Inc.. The 510(k) number is K061638.

When did BEST STRAND AND BEST SPACER receive FDA 510(k) clearance?

BEST STRAND AND BEST SPACER received FDA 510(k) clearance on 2006-08-04, under 510(k) number K061638.

Who is the listed applicant for BEST STRAND AND BEST SPACER?

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 STRAND AND BEST SPACER?

The FDA product code for BEST STRAND AND BEST SPACER 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 BRACHYTHERAPYK043117BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKERK042786BEST MODEL # 81-01 SERIES IR-192 SOURCESK042586BEST BREAST BRACHYTHERAPY APPLICATOR

Related Devices (Code: KXK)

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.

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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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