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FDA 510(k)

DUO DERM FLEX HYDROACTIVE DRESSINGS &

K-Number: K830708 · 1983-05-05

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1983-05-05
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

DUO DERM FLEX HYDROACTIVE DRESSINGS & 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 1983-05-05 under 510(k) number K830708. 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 DUO DERM FLEX HYDROACTIVE DRESSINGS &?

DUO DERM FLEX HYDROACTIVE DRESSINGS & is a medical device that received FDA 510(k) clearance on 1983-05-05. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K830708.

When did DUO DERM FLEX HYDROACTIVE DRESSINGS & receive FDA 510(k) clearance?

DUO DERM FLEX HYDROACTIVE DRESSINGS & received FDA 510(k) clearance on 1983-05-05, under 510(k) number K830708.

Who is the listed applicant for DUO DERM FLEX HYDROACTIVE DRESSINGS &?

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 DUO DERM FLEX HYDROACTIVE DRESSINGS &?

The FDA product code for DUO DERM FLEX HYDROACTIVE DRESSINGS & 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.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN 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.

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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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