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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 K851887
Device Name ON TARGET
Applicant
Newman Assoc.
18662 Macarthur Blvd.
Suite 200
Irvine,  CA  92715
Applicant Contact CHARLES H NEWMAN
Correspondent
Newman Assoc.
18662 Macarthur Blvd.
Suite 200
Irvine,  CA  92715
Correspondent Contact CHARLES H NEWMAN
Classification Product Code
HPX  
Date Received05/01/1985
Decision Date 05/30/1985
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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