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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 -1903
Correspondent
CHIRON VISION CORP.
9342 JERONIMO RD.
IRVINE,  CA  92618 -1903
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
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