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FDA 510(k)

LigaPASS

K-Number: K160698 · 2016-09-02

ApplicantMedicrea International SA
Decision Date2016-09-02
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LigaPASS is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2016-09-02 under approval number K160698. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LigaPASS?

LigaPASS is a medical device that received FDA 510(k) clearance on 2016-09-02. It is manufactured by Medicrea International SA. The 510(k) number is K160698.

When was LigaPASS approved by the FDA?

LigaPASS received FDA 510(k) clearance on 2016-09-02, under approval number K160698.

What company makes LigaPASS?

LigaPASS is manufactured by Medicrea International SA.

What is the FDA product code for LigaPASS?

The FDA product code for LigaPASS is OWI.

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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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