FDA 510(k)

Surgical face mask (Model: Flat Ear Loop/CN102)

K-번호: K203534 · 2021-07-21

신청자Crown Name Disposable Hygiene Products Fty., Ltd.

결정일2021-07-21

제품 코드FXX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Surgical face mask (Model: Flat Ear Loop/CN102) is the device name listed in this FDA 510(k) record. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K203534. 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 Surgical face mask (Model: Flat Ear Loop/CN102)?

Surgical face mask (Model: Flat Ear Loop/CN102) is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Crown Name Disposable Hygiene Products Fty., Ltd.. The 510(k) number is K203534.

When did Surgical face mask (Model: Flat Ear Loop/CN102) receive FDA 510(k) clearance?

Surgical face mask (Model: Flat Ear Loop/CN102) received FDA 510(k) clearance on 2021-07-21, under 510(k) number K203534.

Who is the listed applicant for Surgical face mask (Model: Flat Ear Loop/CN102)?

The FDA 510(k) record lists Crown Name Disposable Hygiene Products Fty., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical face mask (Model: Flat Ear Loop/CN102)?

The FDA product code for Surgical face mask (Model: Flat Ear Loop/CN102) is FXX.

Crown Name Disposable Hygiene Products Fty., Ltd.를 신청인으로 등재한 기타 기록

K212422Disposable Surgical Isolation Gown

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