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FDA 510(k)

DUODERM HYDROACTIVE DRESSING W/BORDER STERILE

K-Number: K853844 · 1985-11-15

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1985-11-15
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

DUODERM HYDROACTIVE DRESSING W/BORDER STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1985-11-15 under 510(k) number K853844. 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 DRESSING W/BORDER STERILE?

DUODERM HYDROACTIVE DRESSING W/BORDER STERILE is a medical device that received FDA 510(k) clearance on 1985-11-15. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K853844.

When did DUODERM HYDROACTIVE DRESSING W/BORDER STERILE receive FDA 510(k) clearance?

DUODERM HYDROACTIVE DRESSING W/BORDER STERILE received FDA 510(k) clearance on 1985-11-15, under 510(k) number K853844.

Who is the listed applicant for DUODERM HYDROACTIVE DRESSING W/BORDER STERILE?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUODERM HYDROACTIVE DRESSING W/BORDER STERILE?

The FDA product code for DUODERM HYDROACTIVE DRESSING W/BORDER STERILE is FRO. This falls under the Anesthesiology category.

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Other records listing Convatec, A Division of E.R. Squibb & Sons 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.

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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.

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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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