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FDA 510(k)

L10 LED Light Source with AIM, L11 LED Light Source with AIM

K-Number: K191046 · 2019-05-10

ApplicantStryker
Decision Date2019-05-10
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

L10 LED Light Source with AIM, L11 LED Light Source with AIM is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2019-05-10 under approval number K191046. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L10 LED Light Source with AIM, L11 LED Light Source with AIM?

L10 LED Light Source with AIM, L11 LED Light Source with AIM is a medical device that received FDA 510(k) clearance on 2019-05-10. It is manufactured by Stryker. The 510(k) number is K191046.

When was L10 LED Light Source with AIM, L11 LED Light Source with AIM approved by the FDA?

L10 LED Light Source with AIM, L11 LED Light Source with AIM received FDA 510(k) clearance on 2019-05-10, under approval number K191046.

What company makes L10 LED Light Source with AIM, L11 LED Light Source with AIM?

L10 LED Light Source with AIM, L11 LED Light Source with AIM is manufactured by Stryker.

What is the FDA product code for L10 LED Light Source with AIM, L11 LED Light Source with AIM?

The FDA product code for L10 LED Light Source with AIM, L11 LED Light Source with AIM is OWN.

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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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