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FDA 510(k)

MODIFICATION TO 3M TEGADERM CHG DRESSING

K-Number: K080620 · 2008-05-19

Applicant3M Company-3M Health Care
Decision Date2008-05-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 3M TEGADERM CHG DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company-3M Health Care. It received FDA 510(k) clearance on 2008-05-19 under 510(k) number K080620. 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 MODIFICATION TO 3M TEGADERM CHG DRESSING?

MODIFICATION TO 3M TEGADERM CHG DRESSING is a medical device that received FDA 510(k) clearance on 2008-05-19. The listed applicant is 3M Company-3M Health Care. The 510(k) number is K080620.

When did MODIFICATION TO 3M TEGADERM CHG DRESSING receive FDA 510(k) clearance?

MODIFICATION TO 3M TEGADERM CHG DRESSING received FDA 510(k) clearance on 2008-05-19, under 510(k) number K080620.

Who is the listed applicant for MODIFICATION TO 3M TEGADERM CHG DRESSING?

The FDA 510(k) record lists 3M Company-3M Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO 3M TEGADERM CHG DRESSING?

The FDA product code for MODIFICATION TO 3M TEGADERM CHG DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing 3M Company-3M Health Care 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.

K1032773M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER

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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