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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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