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FDA 510(k)

Mepiseal Soft Silicone Sealant

K-Number: K152741 · 2016-01-22

ApplicantMolnlycke Health Care Us, LLC
Decision Date2016-01-22
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Mepiseal Soft Silicone Sealant 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 2016-01-22 under 510(k) number K152741. 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 Mepiseal Soft Silicone Sealant?

Mepiseal Soft Silicone Sealant is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K152741.

When did Mepiseal Soft Silicone Sealant receive FDA 510(k) clearance?

Mepiseal Soft Silicone Sealant received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152741.

Who is the listed applicant for Mepiseal Soft Silicone Sealant?

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 Mepiseal Soft Silicone Sealant?

The FDA product code for Mepiseal Soft Silicone Sealant 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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