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FDA 510(k)

GOLDFINGER DEVICE

K-Number: K001162 · 2000-08-09

Decision Date2000-08-09
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GOLDFINGER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Mali-Tech , Ltd.. It received FDA 510(k) clearance on 2000-08-09 under 510(k) number K001162. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLDFINGER DEVICE?

GOLDFINGER DEVICE is a medical device that received FDA 510(k) clearance on 2000-08-09. The listed applicant is Mali-Tech , Ltd.. The 510(k) number is K001162.

When did GOLDFINGER DEVICE receive FDA 510(k) clearance?

GOLDFINGER DEVICE received FDA 510(k) clearance on 2000-08-09, under 510(k) number K001162.

Who is the listed applicant for GOLDFINGER DEVICE?

The FDA 510(k) record lists Mali-Tech , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOLDFINGER DEVICE?

The FDA product code for GOLDFINGER DEVICE is FMK.

Related Clinical Trials

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.

Related Devices (Code: FMK)

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.

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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