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FDA 510(k)

STERILIZATION POUCH WITH INDICATORS

K-Number: K062704 · 2007-06-08

ApplicantWinner Industries (Shenzhen) Co., Ltd.
Decision Date2007-06-08
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILIZATION POUCH WITH INDICATORS is the device name listed in this FDA 510(k) record. The listed applicant is Winner Industries (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2007-06-08 under 510(k) number K062704. 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 STERILIZATION POUCH WITH INDICATORS?

STERILIZATION POUCH WITH INDICATORS is a medical device that received FDA 510(k) clearance on 2007-06-08. The listed applicant is Winner Industries (Shenzhen) Co., Ltd.. The 510(k) number is K062704.

When did STERILIZATION POUCH WITH INDICATORS receive FDA 510(k) clearance?

STERILIZATION POUCH WITH INDICATORS received FDA 510(k) clearance on 2007-06-08, under 510(k) number K062704.

Who is the listed applicant for STERILIZATION POUCH WITH INDICATORS?

The FDA 510(k) record lists Winner Industries (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILIZATION POUCH WITH INDICATORS?

The FDA product code for STERILIZATION POUCH WITH INDICATORS is FRG.

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Other records listing Winner Industries (Shenzhen) 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.

K023755WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD

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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