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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K022760
Device Name MILLENNIUM MICROSURGICAL SYSTEM
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 Number878.4810
Classification Product Code
GEX  
Date Received08/20/2002
Decision Date 11/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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