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FDA 510(k)

AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE

K-Number: K123481 · 2013-06-06

ApplicantConvatec, Inc.
Decision Date2013-06-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, Inc.. It received FDA 510(k) clearance on 2013-06-06 under 510(k) number K123481. 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 AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE?

AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE is a medical device that received FDA 510(k) clearance on 2013-06-06. The listed applicant is Convatec, Inc.. The 510(k) number is K123481.

When did AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE receive FDA 510(k) clearance?

AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE received FDA 510(k) clearance on 2013-06-06, under 510(k) number K123481.

Who is the listed applicant for AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE?

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

What is the FDA product code for AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE?

The FDA product code for AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND 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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