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FDA 510(k)

AGCEL WOUND DRESSING,AGCEL BURN DRESSING

K-Number: K050842 · 2006-08-02

ApplicantModern Medical Equipment Mfg., Ltd.
Decision Date2006-08-02
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

AGCEL WOUND DRESSING,AGCEL BURN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Mfg., Ltd.. It received FDA 510(k) clearance on 2006-08-02 under 510(k) number K050842. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGCEL WOUND DRESSING,AGCEL BURN DRESSING?

AGCEL WOUND DRESSING,AGCEL BURN DRESSING is a medical device that received FDA 510(k) clearance on 2006-08-02. The listed applicant is Modern Medical Equipment Mfg., Ltd.. The 510(k) number is K050842.

When did AGCEL WOUND DRESSING,AGCEL BURN DRESSING receive FDA 510(k) clearance?

AGCEL WOUND DRESSING,AGCEL BURN DRESSING received FDA 510(k) clearance on 2006-08-02, under 510(k) number K050842.

Who is the listed applicant for AGCEL WOUND DRESSING,AGCEL BURN DRESSING?

The FDA 510(k) record lists Modern Medical Equipment Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGCEL WOUND DRESSING,AGCEL BURN DRESSING?

The FDA product code for AGCEL WOUND DRESSING,AGCEL BURN DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Modern Medical Equipment Mfg., 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.

K093479DISPOSABLE SUCTION AND IRRIGATION SYSTEMK091511MODERN MEDICAL RESECTOSCOPE ELECTRODESK070812DISPOSABLE LAPAROSCOPIC INSTRUMENTK070877ENDOCERVICAL ELECTRODE # 2K043036NON-STICK ELECTRODEK033095SMOKE EVACUATION ATTACHEMENT

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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