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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 K802651
Device Name POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
Applicant
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Correspondent
Chiron Vision Corp.
9342 Jeronimo Rd.
Irvine,  CA  92618
Regulation Number886.5844
Classification Product Code
HQG  
Date Received10/24/1980
Decision Date 12/17/1980
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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