FDA 510(k)

PRIMED Surgical Masks and PRIMED Procedure Masks

Número K: K240286 · 2024-08-26

Data da decisão2024-08-26

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRIMED Surgical Masks and PRIMED Procedure Masks is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2024-08-26 under 510(k) number K240286. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PRIMED Surgical Masks and PRIMED Procedure Masks?

PRIMED Surgical Masks and PRIMED Procedure Masks is a medical device that received FDA 510(k) clearance on 2024-08-26. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K240286.

When did PRIMED Surgical Masks and PRIMED Procedure Masks receive FDA 510(k) clearance?

PRIMED Surgical Masks and PRIMED Procedure Masks received FDA 510(k) clearance on 2024-08-26, under 510(k) number K240286.

Who is the listed applicant for PRIMED Surgical Masks and PRIMED Procedure Masks?

The FDA 510(k) record lists Primed Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMED Surgical Masks and PRIMED Procedure Masks?

The FDA product code for PRIMED Surgical Masks and PRIMED Procedure Masks is FXX.

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Outros registros que listam Primed Medical Products, Inc. como candidato(a)

K262007PRIMED AAMI Level 3 Open Back Gowns K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)K252964PRIMED Surgical and Procedure Masks K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K213427PRIMED Pediatric Facemask

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Fonte oficial

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