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FDA 510(k)

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

K-Number: K192292 · 2019-11-19

ApplicantStryker
Decision Date2019-11-19
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2019-11-19 under approval number K192292. 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, AIM SafeLight Cable?

L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable is a medical device that received FDA 510(k) clearance on 2019-11-19. It is manufactured by Stryker. The 510(k) number is K192292.

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

L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable received FDA 510(k) clearance on 2019-11-19, under approval number K192292.

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

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

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

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

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.