FDA 510(k)

Medicom Sterilization Wrap

Numéro K : K240862 · 2024-06-21

Date de décision2024-06-21

Code produitFRG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Medicom Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Medicom Group, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K240862. 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 Medicom Sterilization Wrap?

Medicom Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Medicom Group, Inc.. The 510(k) number is K240862.

When did Medicom Sterilization Wrap receive FDA 510(k) clearance?

Medicom Sterilization Wrap received FDA 510(k) clearance on 2024-06-21, under 510(k) number K240862.

Who is the listed applicant for Medicom Sterilization Wrap?

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

What is the FDA product code for Medicom Sterilization Wrap?

The FDA product code for Medicom Sterilization Wrap 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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