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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 K123764
Device Name DURETTE OCULAR IMPLANT
Applicant
OCULO-PLASTIK, INC.
200, RUE SAUVE OUEST
MONTREAL, QC,  CA H3L 1Y9
Applicant Contact SYLVAIN DESROSIERS
Correspondent
OCULO-PLASTIK, INC.
200, RUE SAUVE OUEST
MONTREAL, QC,  CA H3L 1Y9
Correspondent Contact SYLVAIN DESROSIERS
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received12/07/2012
Decision Date 01/31/2013
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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