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FDA 510(k)

TIDI BRAND STERILIZATION WRAP

K-Number: K042580 · 2004-11-17

ApplicantBanta Healthcare Group, Ltd.
Decision Date2004-11-17
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TIDI BRAND STERILIZATION WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Banta Healthcare Group, Ltd.. It received FDA 510(k) clearance on 2004-11-17 under 510(k) number K042580. 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 TIDI BRAND STERILIZATION WRAP?

TIDI BRAND STERILIZATION WRAP is a medical device that received FDA 510(k) clearance on 2004-11-17. The listed applicant is Banta Healthcare Group, Ltd.. The 510(k) number is K042580.

When did TIDI BRAND STERILIZATION WRAP receive FDA 510(k) clearance?

TIDI BRAND STERILIZATION WRAP received FDA 510(k) clearance on 2004-11-17, under 510(k) number K042580.

Who is the listed applicant for TIDI BRAND STERILIZATION WRAP?

The FDA 510(k) record lists Banta Healthcare Group, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIDI BRAND STERILIZATION WRAP?

The FDA product code for TIDI BRAND STERILIZATION WRAP is FRG.

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Other records listing Banta Healthcare Group, Ltd. as applicant

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K983406SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR

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

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

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