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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 K051127
Device Name KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0
Applicant
Kika Medical, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact HOWARD HOSTEIN
Correspondent
Kika Medical, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact HOWARD HOSTEIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/03/2005
Decision Date 06/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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