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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K033941
Device Name MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
Applicant
BAUSCH & LOMB, INC.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Applicant Contact DENNIS POZZO
Correspondent
BAUSCH & LOMB, INC.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Correspondent Contact DENNIS POZZO
Regulation Number886.4390
Classification Product Code
HQF  
Date Received12/19/2003
Decision Date 02/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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