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FDA 510(k)

COMPEED ATHLETIC DRESSING

K-Number: K883588 · 1988-09-22

ApplicantColoplast A/S
Decision Date1988-09-22
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

COMPEED ATHLETIC DRESSING 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 1988-09-22 under 510(k) number K883588. 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 COMPEED ATHLETIC DRESSING?

COMPEED ATHLETIC DRESSING is a medical device that received FDA 510(k) clearance on 1988-09-22. The listed applicant is Coloplast A/S. The 510(k) number is K883588.

When did COMPEED ATHLETIC DRESSING receive FDA 510(k) clearance?

COMPEED ATHLETIC DRESSING received FDA 510(k) clearance on 1988-09-22, under 510(k) number K883588.

Who is the listed applicant for COMPEED ATHLETIC DRESSING?

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 COMPEED ATHLETIC DRESSING?

The FDA product code for COMPEED ATHLETIC DRESSING 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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