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FDA 510(k)

Safe Secure Sterilization Pouches and Rolls

K-Number: K180139 · 2019-01-03

ApplicantSafe Secure Packing Co., Ltd.
Decision Date2019-01-03
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safe Secure Sterilization Pouches and Rolls is the device name listed in this FDA 510(k) record. The listed applicant is Safe Secure Packing Co., Ltd.. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K180139. 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 Safe Secure Sterilization Pouches and Rolls?

Safe Secure Sterilization Pouches and Rolls is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Safe Secure Packing Co., Ltd.. The 510(k) number is K180139.

When did Safe Secure Sterilization Pouches and Rolls receive FDA 510(k) clearance?

Safe Secure Sterilization Pouches and Rolls received FDA 510(k) clearance on 2019-01-03, under 510(k) number K180139.

Who is the listed applicant for Safe Secure Sterilization Pouches and Rolls?

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

What is the FDA product code for Safe Secure Sterilization Pouches and Rolls?

The FDA product code for Safe Secure Sterilization Pouches and Rolls 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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