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FDA 510(k)

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)

Número K: K182184 · 2019-10-10

RequerenteMdk (Shanghai) Medical Packing Co., Ltd.
Data da decisão2019-10-10
Código do produtoFRG
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) is the device name listed in this FDA 510(k) record. The listed applicant is Mdk (Shanghai) Medical Packing Co., Ltd.. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K182184. 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 Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)?

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Mdk (Shanghai) Medical Packing Co., Ltd.. The 510(k) number is K182184.

When did Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) receive FDA 510(k) clearance?

Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) received FDA 510(k) clearance on 2019-10-10, under 510(k) number K182184.

Who is the listed applicant for Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)?

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

What is the FDA product code for Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)?

The FDA product code for Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) is FRG.

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Dispositivos Relacionados (Código: FRG)

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