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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 a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2016-01-22 under approval 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. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K152741.

When was Mepiseal Soft Silicone Sealant approved by the FDA?

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

What company makes Mepiseal Soft Silicone Sealant?

Mepiseal Soft Silicone Sealant is manufactured by Molnlycke Health Care Us, LLC.

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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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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