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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 (Polymethylmethacrylate)
510(k) Number K895411
Device Name OPTIKEM PMMA CONTACT LENS
Applicant
Optikem Polymers, Inc.
2890 S. Tejon St.
Englewood,  CO  80110
Applicant Contact WILLIAM HOFFMAN
Correspondent
Optikem Polymers, Inc.
2890 S. Tejon St.
Englewood,  CO  80110
Correspondent Contact WILLIAM HOFFMAN
Classification Product Code
HPX  
Date Received09/06/1989
Decision Date 02/27/1990
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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