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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 K900081
Device Name NEW ALLEN IMPLANT
Applicant
Oculo Plastik, Inc.
1170 E.
Henri-Bourassa Blvd.
Montreal, Quebec Canada,  CA H2C 1G4
Applicant Contact JEAN-FRANCOIS DURETT
Correspondent
Oculo Plastik, Inc.
1170 E.
Henri-Bourassa Blvd.
Montreal, Quebec Canada,  CA H2C 1G4
Correspondent Contact JEAN-FRANCOIS DURETT
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received01/04/1990
Decision Date 03/23/1990
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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