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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 K955777
Device Name PMMA CLASIC
Applicant
Rand Scientific Corp.
4135 Northgate Blvd. Suite 9
Sacramento,  CA  95834
Applicant Contact DUANE TRACY
Correspondent
Rand Scientific Corp.
4135 Northgate Blvd. Suite 9
Sacramento,  CA  95834
Correspondent Contact DUANE TRACY
Classification Product Code
HPX  
Date Received12/20/1995
Decision Date 05/16/1996
Decision Substantially Equivalent (SESE)
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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