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FDA 510(k)

Self Sealing Sterilization Pouches

K-Number: K162258 · 2017-04-28

ApplicantTianchang Jiarui Packaging Material Co., Ltd.
Decision Date2017-04-28
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Self Sealing Sterilization Pouches is the device name listed in this FDA 510(k) record. The listed applicant is Tianchang Jiarui Packaging Material Co., Ltd.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K162258. 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 Self Sealing Sterilization Pouches?

Self Sealing Sterilization Pouches is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Tianchang Jiarui Packaging Material Co., Ltd.. The 510(k) number is K162258.

When did Self Sealing Sterilization Pouches receive FDA 510(k) clearance?

Self Sealing Sterilization Pouches received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162258.

Who is the listed applicant for Self Sealing Sterilization Pouches?

The FDA 510(k) record lists Tianchang Jiarui Packaging Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Self Sealing Sterilization Pouches?

The FDA product code for Self Sealing Sterilization Pouches is FRG.

Other records listing Tianchang Jiarui Packaging Material Co., Ltd. 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.

K181957Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted

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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