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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Measuring, Corneal Radius
510(k) Number K864037
Device Name KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER
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 Number886.1450
Classification Product Code
HJB  
Date Received10/16/1986
Decision Date 11/13/1986
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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