FDA 510(k)

ReyaGel (RG03 - MTP gel 3mL)

Número K: K232204 · 2024-04-19

Data da decisão2024-04-19

Código do produtoKGN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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