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FDA 510(k)

Sterilization Pouch and Roll

K-Number: K221875 · 2023-02-13

ApplicantQianjiang Kingphar Medical Packaging & Printing Co., Ltd.
Decision Date2023-02-13
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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