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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Analysis, Anterior Segment
510(k) Number K040913
Device Name NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
Applicant
Bausch & Lomb
180 Via Verde Dr.
San Dimas,  CA  91773
Applicant Contact DAVID THOMAS
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DERWYN REUBER
Regulation Number886.1850
Classification Product Code
MXK  
Subsequent Product Codes
HJO   NCF  
Date Received04/08/2004
Decision Date 07/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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