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FDA 510(k)

Avance Foam Dressing Kit - XL

K-Number: K161935 · 2016-11-04

ApplicantMolnlycke Health Care Us, LLC
Decision Date2016-11-04
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Avance Foam Dressing Kit - XL is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161935. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avance Foam Dressing Kit - XL?

Avance Foam Dressing Kit - XL is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K161935.

When did Avance Foam Dressing Kit - XL receive FDA 510(k) clearance?

Avance Foam Dressing Kit - XL received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161935.

Who is the listed applicant for Avance Foam Dressing Kit - XL?

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

What is the FDA product code for Avance Foam Dressing Kit - XL?

The FDA product code for Avance Foam Dressing Kit - XL is OMP.

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Related Devices (Code: OMP)

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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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