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FDA 510(k)

SELF SEAL STERILIZATION POUCH

K-Number: K071886 · 2007-12-27

ApplicantShanghai Jianzhong Medical Packaging Co., Ltd.
Decision Date2007-12-27
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SELF SEAL STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Jianzhong Medical Packaging Co., Ltd.. It received FDA 510(k) clearance on 2007-12-27 under 510(k) number K071886. 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 SEAL STERILIZATION POUCH?

SELF SEAL STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 2007-12-27. The listed applicant is Shanghai Jianzhong Medical Packaging Co., Ltd.. The 510(k) number is K071886.

When did SELF SEAL STERILIZATION POUCH receive FDA 510(k) clearance?

SELF SEAL STERILIZATION POUCH received FDA 510(k) clearance on 2007-12-27, under 510(k) number K071886.

Who is the listed applicant for SELF SEAL STERILIZATION POUCH?

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

What is the FDA product code for SELF SEAL STERILIZATION POUCH?

The FDA product code for SELF SEAL STERILIZATION POUCH 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 Shanghai Jianzhong Medical Packaging 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.

K242898Sterilization Pouches and ReelsK202341Disposable Surgical Mask

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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