FDA 510(k)

Montblanc Plate System

K-Number: K243368 · 2025-06-04

Decision Date2025-06-04

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Montblanc Plate System is a medical device manufactured by Medifield Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-04 under approval number K243368. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Montblanc Plate System?

Montblanc Plate System is a medical device that received FDA 510(k) clearance on 2025-06-04. It is manufactured by Medifield Medical Co., Ltd.. The 510(k) number is K243368.

When was Montblanc Plate System approved by the FDA?

Montblanc Plate System received FDA 510(k) clearance on 2025-06-04, under approval number K243368.

What company makes Montblanc Plate System?

Montblanc Plate System is manufactured by Medifield Medical Co., Ltd..

What is the FDA product code for Montblanc Plate System?

The FDA product code for Montblanc Plate System is HRS.

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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.