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FDA 510(k)

Avance Gauze Dressing Kits

K-Number: K161948 · 2016-11-03

ApplicantMolnlycke Health Care Us, LLC
Decision Date2016-11-03
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Avance Gauze Dressing Kits 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 2016-11-03 under 510(k) number K161948. 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 Gauze Dressing Kits?

Avance Gauze Dressing Kits is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K161948.

When did Avance Gauze Dressing Kits receive FDA 510(k) clearance?

Avance Gauze Dressing Kits received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161948.

Who is the listed applicant for Avance Gauze Dressing Kits?

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 Gauze Dressing Kits?

The FDA product code for Avance Gauze Dressing Kits is OMP.

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Related Devices (Code: OMP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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