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FDA 510(k)

GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH

K-Number: K990567 · 1999-04-05

ApplicantGlobal Healthcare, Inc.
Decision Date1999-04-05
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Global Healthcare, Inc.. It received FDA 510(k) clearance on 1999-04-05 under 510(k) number K990567. 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 GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH?

GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 1999-04-05. The listed applicant is Global Healthcare, Inc.. The 510(k) number is K990567.

When did GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH receive FDA 510(k) clearance?

GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH received FDA 510(k) clearance on 1999-04-05, under 510(k) number K990567.

Who is the listed applicant for GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH?

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

What is the FDA product code for GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH?

The FDA product code for GLOBAL HEALTHCARE SELF-SEALING 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 Global Healthcare, 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.

K954549SURGICAL APPARELK953754GLOBAL HEALTHCARE FACE 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

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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