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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 K850909
Device Name RHODA-LUX LENS BLANKS
Applicant
Optatint, Inc.
2890 S. Tejon St.
Englewood,  CO  80110
Applicant Contact WILLIAM C HOFFMAN
Correspondent
Optatint, Inc.
2890 S. Tejon St.
Englewood,  CO  80110
Correspondent Contact WILLIAM C HOFFMAN
Classification Product Code
HPX  
Date Received03/05/1985
Decision Date 10/04/1985
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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