FDA 510(k)

MuCover（提案名）口内創傷被覆材

K番号: K253816 · 2026-05-21

決定日2026-05-21

製品コードOLR

決定大幅同等

医療機器の概要

MuCover (proposed name) Oral Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is MoleculeX Co., Ltd.. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K253816. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

よくある質問

What is the MuCover (proposed name) Oral Wound Dressing?

MuCover (proposed name) Oral Wound Dressing is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is MoleculeX Co., Ltd.. The 510(k) number is K253816.

When did MuCover (proposed name) Oral Wound Dressing receive FDA 510(k) clearance?

MuCover (proposed name) Oral Wound Dressing received FDA 510(k) clearance on 2026-05-21, under 510(k) number K253816.

Who is the listed applicant for MuCover (proposed name) Oral Wound Dressing?

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

What is the FDA product code for MuCover (proposed name) Oral Wound Dressing?

The FDA product code for MuCover (proposed name) Oral Wound Dressing is OLR.

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MuCover（提案名）口内創傷被覆材

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：OLR）

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