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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)

K-Number: K182184 · 2019-10-10

ApplicantMdk (Shanghai) Medical Packing Co., Ltd.
Decision Date2019-10-10
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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

When was Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) approved by the FDA?

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 approval number K182184.

What company makes 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 manufactured by Mdk (Shanghai) Medical Packing Co., Ltd..

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.

Related Devices (Code: FRG)

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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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