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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 K850905
Device Name CR-39 TYPE RESIN
Applicant
ORPLEX CORP.
1882 REYNOLDS AVE.
IRVINE,  CA  92714
Applicant Contact HENRY ORLOSKY
Correspondent
ORPLEX CORP.
1882 REYNOLDS AVE.
IRVINE,  CA  92714
Correspondent Contact HENRY ORLOSKY
Regulation Number886.5844
Classification Product Code
HQG  
Date Received03/05/1985
Decision Date 03/20/1985
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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