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FDA 510(k)

CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE

K-Number: K850147 · 1985-07-05

ApplicantBeiersdorf, Inc.
Decision Date1985-07-05
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Beiersdorf, Inc.. It received FDA 510(k) clearance on 1985-07-05 under 510(k) number K850147. 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 for Some Indications.

Frequently Asked Questions

What is the CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE?

CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE is a medical device that received FDA 510(k) clearance on 1985-07-05. The listed applicant is Beiersdorf, Inc.. The 510(k) number is K850147.

When did CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE receive FDA 510(k) clearance?

CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE received FDA 510(k) clearance on 1985-07-05, under 510(k) number K850147.

Who is the listed applicant for CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE?

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

What is the FDA product code for CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE?

The FDA product code for CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE is FRO. This falls under the Anesthesiology category.

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Other records listing Beiersdorf, 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.

K090921ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02K024057CURAD SCAR THERAPYK952526CUTINOVA CAVITYK943363CUTIPLAST STERILK944581CUTINOVA THIN WOUND DRESSINGK935630NORTA

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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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