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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K852403
Device Name AURALITE II
Applicant
Aura Lens Products
P.O. Box 763
St. Cloud,  MN  56302
Applicant Contact ROBERT N AURELIUS
Correspondent
Aura Lens Products
P.O. Box 763
St. Cloud,  MN  56302
Correspondent Contact ROBERT N AURELIUS
Regulation Number886.5844
Classification Product Code
HQG  
Date Received06/06/1985
Decision Date 08/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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