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FDA 510(k)

COMFEEL ULCUS ULCER CARE SYSTEM

K-Number: K873669 · 1987-11-17

ApplicantColoplast A/S
Decision Date1987-11-17
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

COMFEEL ULCUS ULCER CARE SYSTEM 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 1987-11-17 under 510(k) number K873669. 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 COMFEEL ULCUS ULCER CARE SYSTEM?

COMFEEL ULCUS ULCER CARE SYSTEM is a medical device that received FDA 510(k) clearance on 1987-11-17. The listed applicant is Coloplast A/S. The 510(k) number is K873669.

When did COMFEEL ULCUS ULCER CARE SYSTEM receive FDA 510(k) clearance?

COMFEEL ULCUS ULCER CARE SYSTEM received FDA 510(k) clearance on 1987-11-17, under 510(k) number K873669.

Who is the listed applicant for COMFEEL ULCUS ULCER CARE SYSTEM?

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 ULCER CARE SYSTEM?

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

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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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