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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K912904
Device Name MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM
Applicant
MENTOR O & O, INC.
3000 LONGWATER DR.
NORWELL,  MA  02061 -1672
Applicant Contact RICHARD L FOLLETT
Correspondent
MENTOR O & O, INC.
3000 LONGWATER DR.
NORWELL,  MA  02061 -1672
Correspondent Contact RICHARD L FOLLETT
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/02/1991
Decision Date 06/11/1992
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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