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FDA 510(k)

BIODERM SCIENCES WOUND CREAM

K-Number: K042352 · 2005-10-17

ApplicantBioderm Sciences, Inc.
Decision Date2005-10-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

BIODERM SCIENCES WOUND CREAM 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 2005-10-17 under 510(k) number K042352. 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 CREAM?

BIODERM SCIENCES WOUND CREAM is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Bioderm Sciences, Inc.. The 510(k) number is K042352.

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

BIODERM SCIENCES WOUND CREAM received FDA 510(k) clearance on 2005-10-17, under 510(k) number K042352.

Who is the listed applicant for BIODERM SCIENCES WOUND CREAM?

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 CREAM?

The FDA product code for BIODERM SCIENCES WOUND CREAM 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.

K042084BIODERM SCIENCES WOUND HEALING SPRAYK040683BIODERM SCIENCES WOUND DRESSING

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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