FDA 510(k)

Sterilization Pouch and Roll

Numéro K : K221875 · 2023-02-13

DemandeurQianjiang Kingphar Medical Packaging & Printing Co., Ltd.

Date de décision2023-02-13

Code produitFRG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Sterilization Pouch and Roll is the device name listed in this FDA 510(k) record. The listed applicant is Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K221875. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sterilization Pouch and Roll?

Sterilization Pouch and Roll is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.. The 510(k) number is K221875.

When did Sterilization Pouch and Roll receive FDA 510(k) clearance?

Sterilization Pouch and Roll received FDA 510(k) clearance on 2023-02-13, under 510(k) number K221875.

Who is the listed applicant for Sterilization Pouch and Roll?

The FDA 510(k) record lists Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Pouch and Roll?

The FDA product code for Sterilization Pouch and Roll is FRG.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : 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.

Source officielle

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