FDA 510(k)

루오푸콘 PHMB 알진산 드레싱 (처방제 사용), 루오푸콘 PHMB 항균 알진산 드레싱 (OTC 사용)

K-번호: K201016 · 2021-01-28

신청자Huizhou Foryou Medical Devices Co., Ltd.

결정일2021-01-28

제품 코드FRO

결정Substantially Equivalent

기기 요약

LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K201016. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)?

LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K201016.

When did LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) receive FDA 510(k) clearance?

LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) received FDA 510(k) clearance on 2021-01-28, under 510(k) number K201016.

Who is the listed applicant for LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)?

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

What is the FDA product code for LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)?

The FDA product code for LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) is FRO. This falls under the Anesthesiology category.

Huizhou Foryou Medical Devices Co., Ltd.를 신청인으로 등재한 기타 기록

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