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FDA 510(k)

ACTIDERM*-OPAQUE

K-Number: K892232 · 1989-05-05

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1989-05-05
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ACTIDERM*-OPAQUE 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 1989-05-05 under 510(k) number K892232. 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 ACTIDERM*-OPAQUE?

ACTIDERM*-OPAQUE is a medical device that received FDA 510(k) clearance on 1989-05-05. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K892232.

When did ACTIDERM*-OPAQUE receive FDA 510(k) clearance?

ACTIDERM*-OPAQUE received FDA 510(k) clearance on 1989-05-05, under 510(k) number K892232.

Who is the listed applicant for ACTIDERM*-OPAQUE?

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 ACTIDERM*-OPAQUE?

The FDA product code for ACTIDERM*-OPAQUE 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

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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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