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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 K040689
Device Name EYE SPHERE IMPLANTS
Applicant
Oculo Plastik, Inc.
200 Sauve W.
Montreal, Quebec,  CA H3L 1Y9
Applicant Contact JEAN-FRANCOIS DRETTE
Correspondent
Oculo Plastik, Inc.
200 Sauve W.
Montreal, Quebec,  CA H3L 1Y9
Correspondent Contact JEAN-FRANCOIS DRETTE
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received03/16/2004
Decision Date 06/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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