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FDA 510(k)

JAMBRO Single Core A Sterilization wrap

K-Number: K182656 · 2019-06-11

ApplicantJiangsu Zhande Medical Supplies Co., Ltd.
Decision Date2019-06-11
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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, LLCK253454HALYARD* 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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