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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K863200
Device Name COMPUTON(R)
Applicant
Optical Radiation Corp.
1300 Optical Dr.
Azusa,  CA  91702
Applicant Contact CHARMAINE HENDERSON
Correspondent
Optical Radiation Corp.
1300 Optical Dr.
Azusa,  CA  91702
Correspondent Contact CHARMAINE HENDERSON
Regulation Number886.1930
Classification Product Code
HKX  
Date Received08/19/1986
Decision Date 09/03/1986
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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