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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Ophthalmic
510(k) Number K993039
Device Name VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
Applicant
Bausch & Lomb, Inc.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact VANADA JOHNSON
Correspondent
Bausch & Lomb, Inc.
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact VANADA JOHNSON
Regulation Number880.5725
Classification Product Code
MRH  
Date Received09/10/1999
Decision Date 01/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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