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FDA 510(k)

BIODERM SCIENCES WOUND DRESSING

K-Number: K040683 · 2004-06-04

ApplicantBioderm Sciences, Inc.
Decision Date2004-06-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

BIODERM SCIENCES WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Bioderm Sciences, Inc.. It received FDA 510(k) clearance on 2004-06-04 under 510(k) number K040683. 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 BIODERM SCIENCES WOUND DRESSING?

BIODERM SCIENCES WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2004-06-04. The listed applicant is Bioderm Sciences, Inc.. The 510(k) number is K040683.

When did BIODERM SCIENCES WOUND DRESSING receive FDA 510(k) clearance?

BIODERM SCIENCES WOUND DRESSING received FDA 510(k) clearance on 2004-06-04, under 510(k) number K040683.

Who is the listed applicant for BIODERM SCIENCES WOUND DRESSING?

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

What is the FDA product code for BIODERM SCIENCES WOUND DRESSING?

The FDA product code for BIODERM SCIENCES WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Bioderm Sciences, 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.

K042352BIODERM SCIENCES WOUND CREAMK042084BIODERM SCIENCES WOUND HEALING SPRAY

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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