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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Sphere
510(k) Number K873578
Device Name LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT
Applicant
Oculo-Plastik Reg'D
1170, Henri-Bourassa E.
Montreal, Quebec
Canada,  CA H2C 1G4
Applicant Contact JEAN-FRANCOI DURETTE
Correspondent
Oculo-Plastik Reg'D
1170, Henri-Bourassa E.
Montreal, Quebec
Canada,  CA H2C 1G4
Correspondent Contact JEAN-FRANCOI DURETTE
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received09/03/1987
Decision Date 11/02/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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