FDA 510(k)

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

N.º K: K233777 · 2024-05-24

SolicitantePrimed Medical Products, Inc.

Fecha de decisión2024-05-24

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) 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 2024-05-24 under 510(k) number K233777. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K233777.

When did PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) receive FDA 510(k) clearance?

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) received FDA 510(k) clearance on 2024-05-24, under 510(k) number K233777.

Who is the listed applicant for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

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 Sterilization Wrap (P100, P200, P300, P400, P500, P600)?

The FDA product code for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) is FRG.

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Otros registros que enlistan a Primed Medical Products, Inc. como solicitante

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)K240286PRIMED Surgical Masks and PRIMED Procedure Masks K213427PRIMED Pediatric Facemask

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Dispositivos relacionados (Código: FRG)

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLC K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Fuente oficial

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