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FDA 510(k)

Sterilization Package/Reel

K-Number: K241565 · 2025-02-24

ApplicantAnqing Clean Dental Instrument Technology Co., Ltd.
Decision Date2025-02-24
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterilization Package/Reel is the device name listed in this FDA 510(k) record. The listed applicant is Anqing Clean Dental Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-24 under 510(k) number K241565. 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 Package/Reel?

Sterilization Package/Reel is a medical device that received FDA 510(k) clearance on 2025-02-24. The listed applicant is Anqing Clean Dental Instrument Technology Co., Ltd.. The 510(k) number is K241565.

When did Sterilization Package/Reel receive FDA 510(k) clearance?

Sterilization Package/Reel received FDA 510(k) clearance on 2025-02-24, under 510(k) number K241565.

Who is the listed applicant for Sterilization Package/Reel?

The FDA 510(k) record lists Anqing Clean Dental Instrument Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Package/Reel?

The FDA product code for Sterilization Package/Reel 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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