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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K020876
Device Name ECHOSCAN, MODEL US-1800
Applicant
Nidek, Inc.
21911 Erie Ln.
Lake Forest,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
Nidek, Inc.
21911 Erie Ln.
Lake Forest,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/18/2002
Decision Date 05/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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