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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K082132
Device Name BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rodchester,  NY  14609
Applicant Contact NED LUCE
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rodchester,  NY  14609
Correspondent Contact NED LUCE
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/29/2008
Decision Date 08/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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