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FDA 510(k)

MEPILEX AG DRESSING

K-Number: K071354 · 2007-07-13

ApplicantMonlycke Health Care
Decision Date2007-07-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MEPILEX AG DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Monlycke Health Care. It received FDA 510(k) clearance on 2007-07-13 under 510(k) number K071354. 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 MEPILEX AG DRESSING?

MEPILEX AG DRESSING is a medical device that received FDA 510(k) clearance on 2007-07-13. The listed applicant is Monlycke Health Care. The 510(k) number is K071354.

When did MEPILEX AG DRESSING receive FDA 510(k) clearance?

MEPILEX AG DRESSING received FDA 510(k) clearance on 2007-07-13, under 510(k) number K071354.

Who is the listed applicant for MEPILEX AG DRESSING?

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

What is the FDA product code for MEPILEX AG DRESSING?

The FDA product code for MEPILEX AG 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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