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FDA 510(k)

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

K-Number: K153540 · 2016-08-04

ApplicantSafe Secure Packaging Co., Ltd.
Decision Date2016-08-04
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is the device name listed in this FDA 510(k) record. The listed applicant is Safe Secure Packaging Co., Ltd.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153540. 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 Pouch with Steam and Ethylene Oxide Process Indicators?

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Safe Secure Packaging Co., Ltd.. The 510(k) number is K153540.

When did Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators receive FDA 510(k) clearance?

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153540.

Who is the listed applicant for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

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

What is the FDA product code for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators?

The FDA product code for Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators 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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