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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 K023394
Device Name UNISIGHT SYSTEM WITH UNIGATE
Applicant
Electronic Business Machine Co., Ltd. (Ebm)
1600 Kapidlani Blvd.
Suite 1224
Honolulu,  HI  96814
Applicant Contact DAVID LIN
Correspondent
Electronic Business Machine Co., Ltd. (Ebm)
1600 Kapidlani Blvd.
Suite 1224
Honolulu,  HI  96814
Correspondent Contact DAVID LIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/09/2002
Decision Date 01/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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