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FDA 510(k)

AQUACEL Ag Surgical SP Dressing

K-Number: K152926 · 2016-01-21

ApplicantConvatec Limited
Decision Date2016-01-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

AQUACEL Ag Surgical SP Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K152926. 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 Surgical SP Dressing?

AQUACEL Ag Surgical SP Dressing is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Convatec Limited. The 510(k) number is K152926.

When did AQUACEL Ag Surgical SP Dressing receive FDA 510(k) clearance?

AQUACEL Ag Surgical SP Dressing received FDA 510(k) clearance on 2016-01-21, under 510(k) number K152926.

Who is the listed applicant for AQUACEL Ag Surgical SP Dressing?

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

What is the FDA product code for AQUACEL Ag Surgical SP Dressing?

The FDA product code for AQUACEL Ag Surgical SP Dressing 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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