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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name photokeratoscope
510(k) Number K901523
Device Name VKG 1000, VIDEO KERATOGRAPH
Applicant
THE SANBORN CO.
5181 LAFAYETTE ST.
SANTA CLARA,  CA  95054
Applicant Contact CARL R JORDAN
Correspondent
THE SANBORN CO.
5181 LAFAYETTE ST.
SANTA CLARA,  CA  95054
Correspondent Contact CARL R JORDAN
Regulation Number886.1350
Classification Product Code
HJA  
Date Received04/02/1990
Decision Date 06/27/1990
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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