FDA 510(k)

ReyaGel (RG03 - MTP gel 3mL)

K-번호: K232204 · 2024-04-19

결정일2024-04-19

제품 코드KGN

결정Substantially Equivalent

기기 요약

ReyaGel (RG03 - MTP gel 3mL) is the device name listed in this FDA 510(k) record. The listed applicant is Fettech. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K232204. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ReyaGel (RG03 - MTP gel 3mL)?

ReyaGel (RG03 - MTP gel 3mL) is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Fettech. The 510(k) number is K232204.

When did ReyaGel (RG03 - MTP gel 3mL) receive FDA 510(k) clearance?

ReyaGel (RG03 - MTP gel 3mL) received FDA 510(k) clearance on 2024-04-19, under 510(k) number K232204.

Who is the listed applicant for ReyaGel (RG03 - MTP gel 3mL)?

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

What is the FDA product code for ReyaGel (RG03 - MTP gel 3mL)?

The FDA product code for ReyaGel (RG03 - MTP gel 3mL) is KGN.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

ReyaGel (RG03 - MTP gel 3mL)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KGN)

공식 출처