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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 K915630
Device Name OPHTIMPLANT
Applicant
OCULO PLASTIK, INC.
1170 EAST
HENRI-BOURASSA BLVD.
MONTREAL, QUEBEC CANADA,  CA H2C 1G4
Applicant Contact DURETTE
Correspondent
OCULO PLASTIK, INC.
1170 EAST
HENRI-BOURASSA BLVD.
MONTREAL, QUEBEC CANADA,  CA H2C 1G4
Correspondent Contact DURETTE
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received12/17/1991
Decision Date 03/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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