FDA 510(k)

PERMALOOP Suture, PERMATAPE Suture

Número K: K220219 · 2022-04-26

Data da decisão2022-04-26

Código do produtoGAT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PERMALOOP Suture, PERMATAPE Suture is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2022-04-26 under 510(k) number K220219. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PERMALOOP Suture, PERMATAPE Suture?

PERMALOOP Suture, PERMATAPE Suture is a medical device that received FDA 510(k) clearance on 2022-04-26. The listed applicant is Medos International SARL. The 510(k) number is K220219.

When did PERMALOOP Suture, PERMATAPE Suture receive FDA 510(k) clearance?

PERMALOOP Suture, PERMATAPE Suture received FDA 510(k) clearance on 2022-04-26, under 510(k) number K220219.

Who is the listed applicant for PERMALOOP Suture, PERMATAPE Suture?

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

What is the FDA product code for PERMALOOP Suture, PERMATAPE Suture?

The FDA product code for PERMALOOP Suture, PERMATAPE Suture is GAT.

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Fonte oficial

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