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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer, Ophthalmic
510(k) Number K000327
Device Name WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
Applicant
VISX, INCORPORATED
3400 CENTRAL EXPRESSWAY
SANTA CLARA,  CA  95051 -0703
Applicant Contact DAVID M PATINO
Correspondent
VISX, INCORPORATED
3400 CENTRAL EXPRESSWAY
SANTA CLARA,  CA  95051 -0703
Correspondent Contact DAVID M PATINO
Regulation Number886.1760
Classification Product Code
HKO  
Date Received02/02/2000
Decision Date 05/02/2000
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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