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510(k) Data Aggregation
K Number
K972661Device Name
EYE SPHERE, CONFORMERS
Manufacturer
GULDEN OPHTHALMICS
Date Cleared
1997-10-03
(79 days)
Product Code
HPZ
Regulation Number
886.3320Why did this record match?
Applicant Name (Manufacturer) :
GULDEN OPHTHALMICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Eye Spheres: To occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration).
Conformers: To maintain the shape of the eye and prevent closure or adhesion during the healing process.
Device Description
Eye Spheres: Eye spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration).
Conformers: Conformers are temporary devices that maintain the shape of the eye and prevent closure or adhesion during the healing process.
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