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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Manual
510(k) Number K011199
Device Name PROVIEW EYE PRESSURE MONITOR
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609 -3547
Applicant Contact DOUGLAS J FORTUNATO
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609 -3547
Correspondent Contact DOUGLAS J FORTUNATO
Regulation Number886.1930
Classification Product Code
HKY  
Date Received04/19/2001
Decision Date 07/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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