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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
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