FDA 510(k)

Self Sealing Sterilization Pouches

Número K: K243721 · 2025-04-25

RequerenteWellmed Dental Medical Supply Co., Ltd.

Data da decisão2025-04-25

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Self Sealing Sterilization Pouches is the device name listed in this FDA 510(k) record. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243721. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Self Sealing Sterilization Pouches?

Self Sealing Sterilization Pouches is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Wellmed Dental Medical Supply Co., Ltd.. The 510(k) number is K243721.

When did Self Sealing Sterilization Pouches receive FDA 510(k) clearance?

Self Sealing Sterilization Pouches received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243721.

Who is the listed applicant for Self Sealing Sterilization Pouches?

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

What is the FDA product code for Self Sealing Sterilization Pouches?

The FDA product code for Self Sealing Sterilization Pouches is FRG.

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Outros registros que listam Wellmed Dental Medical Supply Co., Ltd. como candidato(a)

K242435Dental Barrier and Sleeves K222697Disposable Medical Face Mask (DF3-001)

Dispositivos Relacionados (Código: 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.

Fonte oficial

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