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FDA 510(k)

DUODERM HYDROACTIVE PASTE

K-Number: K973807 · 1997-12-23

ApplicantConvatec, A Bristol-Myers Squibb Co.
Decision Date1997-12-23
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

DUODERM HYDROACTIVE PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Bristol-Myers Squibb Co.. It received FDA 510(k) clearance on 1997-12-23 under 510(k) number K973807. 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 DUODERM HYDROACTIVE PASTE?

DUODERM HYDROACTIVE PASTE is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Convatec, A Bristol-Myers Squibb Co.. The 510(k) number is K973807.

When did DUODERM HYDROACTIVE PASTE receive FDA 510(k) clearance?

DUODERM HYDROACTIVE PASTE received FDA 510(k) clearance on 1997-12-23, under 510(k) number K973807.

Who is the listed applicant for DUODERM HYDROACTIVE PASTE?

The FDA 510(k) record lists Convatec, A Bristol-Myers Squibb Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUODERM HYDROACTIVE PASTE?

The FDA product code for DUODERM HYDROACTIVE PASTE is FRO. This falls under the Anesthesiology category.

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Other records listing Convatec, A Bristol-Myers Squibb Co. 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.

K032734CONVATEC FECAL MANAGEMENT SYSTEMK990368DUODERM HYDROACTIVE GEL WOUND DRESSINGK982116AQUACEL HYDROFIBER WOUND DRESSINGK973806DUODERM HYDROACTIVE GELK973717COMBIDERM ACDK973716DUODERM EXTRA THIN CGF DRESSING

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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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