FDA 510(k)

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K-번호: K221134 · 2022-05-19

결정일2022-05-19

제품 코드FXX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Procedure Mask with Ear Loops and Surgical Mask with Ties is the device name listed in this FDA 510(k) record. The listed applicant is Safesource Direct, LLC. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K221134. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Procedure Mask with Ear Loops and Surgical Mask with Ties?

Procedure Mask with Ear Loops and Surgical Mask with Ties is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Safesource Direct, LLC. The 510(k) number is K221134.

When did Procedure Mask with Ear Loops and Surgical Mask with Ties receive FDA 510(k) clearance?

Procedure Mask with Ear Loops and Surgical Mask with Ties received FDA 510(k) clearance on 2022-05-19, under 510(k) number K221134.

Who is the listed applicant for Procedure Mask with Ear Loops and Surgical Mask with Ties?

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

What is the FDA product code for Procedure Mask with Ear Loops and Surgical Mask with Ties?

The FDA product code for Procedure Mask with Ear Loops and Surgical Mask with Ties is FXX.

Safesource Direct, LLC를 신청인으로 등재한 기타 기록

K250502SafeSource 디렉트 블루 파우더 프리 니트릴 검사 장갑 (AMERI-TUFF 시리즈 4000, AMERI-TOUCH 시리즈 5000)K222898SafeSource 디렉트 블루 포워드리스 니트림 검사 장갑

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