FDA 510(k)

JAMBRO Single Core A Sterilization wrap

Numéro K : K182656 · 2019-06-11

DemandeurJiangsu Zhande Medical Supplies Co., Ltd.

Date de décision2019-06-11

Code produitFRG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

JAMBRO Single Core A Sterilization wrap is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Zhande Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2019-06-11 under 510(k) number K182656. 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 JAMBRO Single Core A Sterilization wrap?

JAMBRO Single Core A Sterilization wrap is a medical device that received FDA 510(k) clearance on 2019-06-11. The listed applicant is Jiangsu Zhande Medical Supplies Co., Ltd.. The 510(k) number is K182656.

When did JAMBRO Single Core A Sterilization wrap receive FDA 510(k) clearance?

JAMBRO Single Core A Sterilization wrap received FDA 510(k) clearance on 2019-06-11, under 510(k) number K182656.

Who is the listed applicant for JAMBRO Single Core A Sterilization wrap?

The FDA 510(k) record lists Jiangsu Zhande Medical Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAMBRO Single Core A Sterilization wrap?

The FDA product code for JAMBRO Single Core A Sterilization wrap is FRG.

Essais cliniques associés

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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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