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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Ac-Powered
510(k) Number K871479
Device Name VIDEOSCAN (TM)
Applicant
Kera Corp.
2362 Walsh Ave.
Santa Clara,  CA  95051
Applicant Contact WILLIAM B COLLINS
Correspondent
Kera Corp.
2362 Walsh Ave.
Santa Clara,  CA  95051
Correspondent Contact WILLIAM B COLLINS
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received04/14/1987
Decision Date 05/22/1987
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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