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FDA 510(k)

CONTREET FOAM ADHESIVE/NON-ADHESIVE

K-Number: K022416 · 2003-02-03

ApplicantColoplast Corp.
Decision Date2003-02-03
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

CONTREET FOAM ADHESIVE/NON-ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2003-02-03 under 510(k) number K022416. 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 CONTREET FOAM ADHESIVE/NON-ADHESIVE?

CONTREET FOAM ADHESIVE/NON-ADHESIVE is a medical device that received FDA 510(k) clearance on 2003-02-03. The listed applicant is Coloplast Corp.. The 510(k) number is K022416.

When did CONTREET FOAM ADHESIVE/NON-ADHESIVE receive FDA 510(k) clearance?

CONTREET FOAM ADHESIVE/NON-ADHESIVE received FDA 510(k) clearance on 2003-02-03, under 510(k) number K022416.

Who is the listed applicant for CONTREET FOAM ADHESIVE/NON-ADHESIVE?

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

What is the FDA product code for CONTREET FOAM ADHESIVE/NON-ADHESIVE?

The FDA product code for CONTREET FOAM ADHESIVE/NON-ADHESIVE 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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