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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 K071266
Device Name BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609 -3547
Applicant Contact MICHAEL A SANTALUCIA
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609 -3547
Correspondent Contact MICHAEL A SANTALUCIA
Regulation Number886.5916
Classification Product Code
HQD  
Subsequent Product Code
MUW  
Date Received05/07/2007
Decision Date 08/15/2007
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
Recalls CDRH Recalls
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