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FDA 510(k)

CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)

K-Number: K033869 · 2004-05-17

ApplicantColoplast Corp.
Decision Date2004-05-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2004-05-17 under 510(k) number K033869. 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 CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)?

CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) is a medical device that received FDA 510(k) clearance on 2004-05-17. The listed applicant is Coloplast Corp.. The 510(k) number is K033869.

When did CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) receive FDA 510(k) clearance?

CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) received FDA 510(k) clearance on 2004-05-17, under 510(k) number K033869.

Who is the listed applicant for CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)?

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 CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)?

The FDA product code for CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) 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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