FDA 510(k)

NaturaJel™ Oral Wound Care Kit

K番号: K260120 · 2026-08-05

決定日2026-08-05

製品コードOLR

決定Substantially Equivalent

医療機器の概要

NaturaJel™ Oral Wound Care Kit is the device name listed in this FDA 510(k) record. The listed applicant is HCS Innovation, LLC. It received FDA 510(k) clearance on 2026-08-05 under 510(k) number K260120. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

よくある質問

What is the NaturaJel™ Oral Wound Care Kit?

NaturaJel™ Oral Wound Care Kit is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is HCS Innovation, LLC. The 510(k) number is K260120.

When did NaturaJel™ Oral Wound Care Kit receive FDA 510(k) clearance?

NaturaJel™ Oral Wound Care Kit received FDA 510(k) clearance on 2026-08-05, under 510(k) number K260120.

Who is the listed applicant for NaturaJel™ Oral Wound Care Kit?

The FDA 510(k) record lists HCS Innovation, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NaturaJel™ Oral Wound Care Kit?

The FDA product code for NaturaJel™ Oral Wound Care Kit is OLR.

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NaturaJel™ Oral Wound Care Kit

医療機器の概要

よくある質問

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