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FDA 510(k)

MEDLINE STERISET STERILIZATION CONTAINER

K-Number: K010825 · 2001-05-08

ApplicantMedline
Decision Date2001-05-08
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDLINE STERISET STERILIZATION CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Medline. It received FDA 510(k) clearance on 2001-05-08 under 510(k) number K010825. 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 MEDLINE STERISET STERILIZATION CONTAINER?

MEDLINE STERISET STERILIZATION CONTAINER is a medical device that received FDA 510(k) clearance on 2001-05-08. The listed applicant is Medline. The 510(k) number is K010825.

When did MEDLINE STERISET STERILIZATION CONTAINER receive FDA 510(k) clearance?

MEDLINE STERISET STERILIZATION CONTAINER received FDA 510(k) clearance on 2001-05-08, under 510(k) number K010825.

Who is the listed applicant for MEDLINE STERISET STERILIZATION CONTAINER?

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

What is the FDA product code for MEDLINE STERISET STERILIZATION CONTAINER?

The FDA product code for MEDLINE STERISET STERILIZATION CONTAINER is FRG.

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Other records listing Medline as applicant

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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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