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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 K073293
Device Name DURETTE IMPLANT
Applicant
OCULO PLASTIK, INC.
200 SAUVE WEST
MONTREAL, QC,  CA H3L 1Y9
Applicant Contact JEAN-FRANCOIS DURETTE
Correspondent
OCULO PLASTIK, INC.
200 SAUVE WEST
MONTREAL, QC,  CA H3L 1Y9
Correspondent Contact JEAN-FRANCOIS DURETTE
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received11/23/2007
Decision Date 03/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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