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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K071166
Device Name UNIWEB, VERSION 5.0
Applicant
Electronic Business Machine Co., Ltd. (Ebm)
1600 Kapiolani Blvd.
Suite 1300
Honolulu,  HI  96814
Applicant Contact ANDY YEW
Correspondent
Electronic Business Machine Co., Ltd. (Ebm)
1600 Kapiolani Blvd.
Suite 1300
Honolulu,  HI  96814
Correspondent Contact ANDY YEW
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/26/2007
Decision Date 07/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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