FDA 510(k)

STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM

K-Number: K023614 · 2003-04-07

Decision Date2003-04-07

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical, Inc.. It received FDA 510(k) clearance on 2003-04-07 under 510(k) number K023614. 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 STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM?

STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-07. The listed applicant is Case Medical, Inc.. The 510(k) number is K023614.

When did STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM receive FDA 510(k) clearance?

STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM received FDA 510(k) clearance on 2003-04-07, under 510(k) number K023614.

Who is the listed applicant for STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM?

The FDA 510(k) record lists Case Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM?

The FDA product code for STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM is FRG.

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Other records listing Case Medical, Inc. as applicant

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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

View on FDA Database →

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