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510(k) K203569

Device
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
Applicant
FCI (France Chirurgie Instrumentation) SAS
510(k) number
K203569
Product code
NCB  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-11
Date received
2020-12-07
Regulation
886.5700
Classification name
Weights, Eyelid, Implantable
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Thierry Fetick
Address
20-22 Rue Louis Armand Paris FR 75015 75015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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