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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 K920795
Device Name 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
Applicant
Optical Radiation Corp.
1300 Optical Dr.
Azusa,  CA  91702
Applicant Contact ENID ROKAW
Correspondent
Optical Radiation Corp.
1300 Optical Dr.
Azusa,  CA  91702
Correspondent Contact ENID ROKAW
Regulation Number886.5844
Classification Product Code
HQG  
Date Received02/21/1992
Decision Date 07/13/1992
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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