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FDA 510(k)

Endocular Viewing Lenses and Silicone Ring

K-Number: K173944 · 2018-10-25

ApplicantPhakos
Decision Date2018-10-25
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Endocular Viewing Lenses and Silicone Ring is a medical device manufactured by Phakos. It received FDA 510(k) clearance on 2018-10-25 under approval number K173944. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endocular Viewing Lenses and Silicone Ring?

Endocular Viewing Lenses and Silicone Ring is a medical device that received FDA 510(k) clearance on 2018-10-25. It is manufactured by Phakos. The 510(k) number is K173944.

When was Endocular Viewing Lenses and Silicone Ring approved by the FDA?

Endocular Viewing Lenses and Silicone Ring received FDA 510(k) clearance on 2018-10-25, under approval number K173944.

What company makes Endocular Viewing Lenses and Silicone Ring?

Endocular Viewing Lenses and Silicone Ring is manufactured by Phakos.

What is the FDA product code for Endocular Viewing Lenses and Silicone Ring?

The FDA product code for Endocular Viewing Lenses and Silicone Ring is HJK.

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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.