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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 K760126
Device Name LENS, HARD CONTACT
Applicant
TRU-FORM OPTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRU-FORM OPTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Classification Product Code
HPX  
Date Received06/28/1976
Decision Date 07/20/1976
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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