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FDA 510(k)

X-STEN MILD TOOL KIT, MODEL MTK-0001

K-Number: K062038 · 2006-12-19

ApplicantX-Sten Corp.
Decision Date2006-12-19
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-STEN MILD TOOL KIT, MODEL MTK-0001 is the device name listed in this FDA 510(k) record. The listed applicant is X-Sten Corp.. It received FDA 510(k) clearance on 2006-12-19 under 510(k) number K062038. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-STEN MILD TOOL KIT, MODEL MTK-0001?

X-STEN MILD TOOL KIT, MODEL MTK-0001 is a medical device that received FDA 510(k) clearance on 2006-12-19. The listed applicant is X-Sten Corp.. The 510(k) number is K062038.

When did X-STEN MILD TOOL KIT, MODEL MTK-0001 receive FDA 510(k) clearance?

X-STEN MILD TOOL KIT, MODEL MTK-0001 received FDA 510(k) clearance on 2006-12-19, under 510(k) number K062038.

Who is the listed applicant for X-STEN MILD TOOL KIT, MODEL MTK-0001?

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

What is the FDA product code for X-STEN MILD TOOL KIT, MODEL MTK-0001?

The FDA product code for X-STEN MILD TOOL KIT, MODEL MTK-0001 is HRX.

Related Clinical Trials

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Other records listing X-Sten 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.

K093062VERTOS MEDICAL MILD DEVICE KIT

Related Devices (Code: HRX)

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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