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FDA 510(k)

Filbloc

K-Number: K150553 · 2016-05-19

ApplicantAssut Europe
Decision Date2016-05-19
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Filbloc is a medical device manufactured by Assut Europe. It received FDA 510(k) clearance on 2016-05-19 under approval number K150553. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Filbloc?

Filbloc is a medical device that received FDA 510(k) clearance on 2016-05-19. It is manufactured by Assut Europe. The 510(k) number is K150553.

When was Filbloc approved by the FDA?

Filbloc received FDA 510(k) clearance on 2016-05-19, under approval number K150553.

What company makes Filbloc?

Filbloc is manufactured by Assut Europe.

What is the FDA product code for Filbloc?

The FDA product code for Filbloc is NEW.

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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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