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FDA 510(k)

COMFEEL ULCUS SHEET

K-Number: K840438 · 1984-11-07

ApplicantColoplast A/S
Decision Date1984-11-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

COMFEEL ULCUS SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 1984-11-07 under 510(k) number K840438. 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 COMFEEL ULCUS SHEET?

COMFEEL ULCUS SHEET is a medical device that received FDA 510(k) clearance on 1984-11-07. The listed applicant is Coloplast A/S. The 510(k) number is K840438.

When did COMFEEL ULCUS SHEET receive FDA 510(k) clearance?

COMFEEL ULCUS SHEET received FDA 510(k) clearance on 1984-11-07, under 510(k) number K840438.

Who is the listed applicant for COMFEEL ULCUS SHEET?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFEEL ULCUS SHEET?

The FDA product code for COMFEEL ULCUS SHEET is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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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