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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K980133
Device Name BAUSCH & LOMB WETTING AND SOAKING SOLUTION
Applicant
Polymer Technology Corp.
1400 N Goodman St.
Rochester,  NY  14692
Applicant Contact DEBRA L.B. KETCHUM
Correspondent
Polymer Technology Corp.
1400 N Goodman St.
Rochester,  NY  14692
Correspondent Contact DEBRA L.B. KETCHUM
Regulation Number886.5928
Classification Product Code
LPN  
Date Received01/15/1998
Decision Date 03/11/1998
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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