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FDA 510(k)

SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP

K-Number: K984204 · 2007-03-19

ApplicantArgentum International, LLC
Decision Date2007-03-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Argentum International, LLC. It received FDA 510(k) clearance on 2007-03-19 under 510(k) number K984204. 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 SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP?

SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP is a medical device that received FDA 510(k) clearance on 2007-03-19. The listed applicant is Argentum International, LLC. The 510(k) number is K984204.

When did SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP receive FDA 510(k) clearance?

SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP received FDA 510(k) clearance on 2007-03-19, under 510(k) number K984204.

Who is the listed applicant for SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP?

The FDA 510(k) record lists Argentum International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP?

The FDA product code for SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP is FRO. This falls under the Anesthesiology category.

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Other records listing Argentum International, LLC 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.

K984207SILVERLON DIRECT PRESSURE WOUND DRESSINGK984205SILVERLON ADHESIVE STRIPK023612SILVERLON CONTACT WOUND DRESSINGK023609SILVERLON ADHESIVE STRIPK984210SILVERLON WOUND PACKING STRIPSK984208SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD

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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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