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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 K970698
Device Name BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
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 Number886.5916
Classification Product Code
HQD  
Date Received02/25/1997
Decision Date 05/06/1997
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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