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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 K073184
Device Name BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
Applicant
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14609 -3547
Applicant Contact DEBRA KETCHUM
Correspondent
BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER,  NY  14609 -3547
Correspondent Contact DEBRA KETCHUM
Regulation Number886.5916
Classification Product Code
HQD  
Date Received11/13/2007
Decision Date 02/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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