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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 K821398
Device Name CORNING CPF 550 LENS
Applicant
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Corning Medical & Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.5844
Classification Product Code
HQG  
Date Received05/11/1982
Decision Date 06/25/1982
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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