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FDA 510(k)

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants

K-Number: K203569 · 2021-06-11

ApplicantFci (France Chirurgie Instrumentation) Sas
Decision Date2021-06-11
Product CodeNCB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants is the device name listed in this FDA 510(k) record. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K203569. The device is classified under product code NCB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants?

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Fci (France Chirurgie Instrumentation) Sas. The 510(k) number is K203569.

When did Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants receive FDA 510(k) clearance?

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants received FDA 510(k) clearance on 2021-06-11, under 510(k) number K203569.

Who is the listed applicant for Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants?

The FDA 510(k) record lists Fci (France Chirurgie Instrumentation) Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants?

The FDA product code for Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants is NCB.

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Official Source

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