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FDA 510(k)

MDT CHEMITEST SEE-THRU BAG

K-Number: K831425 · 1983-06-02

ApplicantKenpak Converters, Inc.
Decision Date1983-06-02
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MDT CHEMITEST SEE-THRU BAG is the device name listed in this FDA 510(k) record. The listed applicant is Kenpak Converters, Inc.. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K831425. 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 MDT CHEMITEST SEE-THRU BAG?

MDT CHEMITEST SEE-THRU BAG is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Kenpak Converters, Inc.. The 510(k) number is K831425.

When did MDT CHEMITEST SEE-THRU BAG receive FDA 510(k) clearance?

MDT CHEMITEST SEE-THRU BAG received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831425.

Who is the listed applicant for MDT CHEMITEST SEE-THRU BAG?

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

What is the FDA product code for MDT CHEMITEST SEE-THRU BAG?

The FDA product code for MDT CHEMITEST SEE-THRU BAG is FRG.

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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

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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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