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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 K973756
Device Name EYE SYS VISTA
Applicant
Eyesys Technologies, Inc.
2776 Bingle
Houston,  TX  77055
Applicant Contact BETH A SOPER
Correspondent
Eyesys Technologies, Inc.
2776 Bingle
Houston,  TX  77055
Correspondent Contact BETH A SOPER
Regulation Number886.1350
Classification Product Code
HLQ  
Subsequent Product Code
HJA  
Date Received10/02/1997
Decision Date 11/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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