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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 K973217
Device Name BOSTON LIQUID ENZYMATIC CLEANER
Applicant
Polymer Technology Corp.
1400 N Goodman St.
Rochester,  NY  14692
Applicant Contact DOUGLAS J FORTUNATO
Correspondent
Polymer Technology Corp.
1400 N Goodman St.
Rochester,  NY  14692
Correspondent Contact DOUGLAS J FORTUNATO
Regulation Number886.5928
Classification Product Code
LPN  
Date Received08/27/1997
Decision Date 11/24/1997
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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