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FDA 510(k)

TOP FINE

K-Number: K063466 · 2007-03-02

ApplicantDaejin Tech Medical Manufacturing Co., Ltd.
Decision Date2007-03-02
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TOP FINE is the device name listed in this FDA 510(k) record. The listed applicant is Daejin Tech Medical Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2007-03-02 under 510(k) number K063466. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOP FINE?

TOP FINE is a medical device that received FDA 510(k) clearance on 2007-03-02. The listed applicant is Daejin Tech Medical Manufacturing Co., Ltd.. The 510(k) number is K063466.

When did TOP FINE receive FDA 510(k) clearance?

TOP FINE received FDA 510(k) clearance on 2007-03-02, under 510(k) number K063466.

Who is the listed applicant for TOP FINE?

The FDA 510(k) record lists Daejin Tech Medical Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOP FINE?

The FDA product code for TOP FINE is FMI.

Other records listing Daejin Tech Medical Manufacturing Co., Ltd. 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.

K063348TOP FINE INSULIN SYRINGE

Related Devices (Code: FMI)

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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