FDA 510(k)

SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS

K-Number: K112591 · 2012-02-07

ApplicantSafe Secure Packaging Co., Ltd.

Decision Date2012-02-07

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SAFE SECURE STERILIZATION POUNCH 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 2012-02-07 under 510(k) number K112591. 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 POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS?

SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS is a medical device that received FDA 510(k) clearance on 2012-02-07. The listed applicant is Safe Secure Packaging Co., Ltd.. The 510(k) number is K112591.

When did SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS receive FDA 510(k) clearance?

SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS received FDA 510(k) clearance on 2012-02-07, under 510(k) number K112591.

Who is the listed applicant for SAFE SECURE STERILIZATION POUNCH 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 POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS?

The FDA product code for SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS is FRG.

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Other records listing Safe Secure Packaging Co., Ltd. as applicant

K153540Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

Related Devices (Code: 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.