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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K022128
Device Name BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Applicant
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rodchester,  NY  14609
Applicant Contact DEBRA L KETCHUM
Correspondent
Bausch & Lomb, Incorporated
1400 N. Goodman St.
Rodchester,  NY  14609
Correspondent Contact DEBRA L KETCHUM
Regulation Number886.5916
Classification Product Code
HQD  
Date Received07/01/2002
Decision Date 08/22/2002
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
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