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FDA 510(k)

MONARCH STERILIZATION CONTAINER SYSTEM

K-Number: K850289 · 1985-08-15

ApplicantMonarch Products, Inc.
Decision Date1985-08-15
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MONARCH STERILIZATION CONTAINER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Monarch Products, Inc.. It received FDA 510(k) clearance on 1985-08-15 under 510(k) number K850289. 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 MONARCH STERILIZATION CONTAINER SYSTEM?

MONARCH STERILIZATION CONTAINER SYSTEM is a medical device that received FDA 510(k) clearance on 1985-08-15. The listed applicant is Monarch Products, Inc.. The 510(k) number is K850289.

When did MONARCH STERILIZATION CONTAINER SYSTEM receive FDA 510(k) clearance?

MONARCH STERILIZATION CONTAINER SYSTEM received FDA 510(k) clearance on 1985-08-15, under 510(k) number K850289.

Who is the listed applicant for MONARCH STERILIZATION CONTAINER SYSTEM?

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

What is the FDA product code for MONARCH STERILIZATION CONTAINER SYSTEM?

The FDA product code for MONARCH STERILIZATION CONTAINER SYSTEM is FRG.

Related Clinical Trials

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.

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Other records listing Monarch Products, Inc. as applicant

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.

K911760MONARCH STERILIZATION CONTAINER SYST, MODIFICATION

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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