FDA 510(k)

Barrigel Injectable Gel

K-번호: K220641 · 2022-05-26

결정일2022-05-26

제품 코드OVB

자문 위원회RA

결정Substantially Equivalent

기기 요약

Barrigel Injectable Gel is the device name listed in this FDA 510(k) record. The listed applicant is Palette Life Sciences. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K220641. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Barrigel Injectable Gel?

Barrigel Injectable Gel is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is Palette Life Sciences. The 510(k) number is K220641.

When did Barrigel Injectable Gel receive FDA 510(k) clearance?

Barrigel Injectable Gel received FDA 510(k) clearance on 2022-05-26, under 510(k) number K220641.

Who is the listed applicant for Barrigel Injectable Gel?

The FDA 510(k) record lists Palette Life Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Barrigel Injectable Gel?

The FDA product code for Barrigel Injectable Gel is OVB.

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Barrigel Injectable Gel

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OVB)

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