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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 K934834
Device Name EPTFE SHEET COVERING FOR OCULAR IMPLANT
Applicant
Oculo Plastik, Inc.
1170 E.
Henri-Bourassa Blvd.
Montreal, Quebec Canada,  CA H2C 1G4
Applicant Contact JEAN F DURETTE
Correspondent
Oculo Plastik, Inc.
1170 E.
Henri-Bourassa Blvd.
Montreal, Quebec Canada,  CA H2C 1G4
Correspondent Contact JEAN F DURETTE
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received10/08/1993
Decision Date 05/05/1994
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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