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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Alcohol, Device Disinfectant
510(k) Number K890514
Device Name PRE-MOISTENED CLEANSING PAD
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Applicant Contact DAVIES, O.D.
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
P.O.Box 450
Rochester,  NY  14692
Correspondent Contact DAVIES, O.D.
Classification Product Code
LKB  
Date Received02/01/1989
Decision Date 04/10/1989
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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