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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 K133609
Device Name THE DOME S6C
Applicant
Nds Surgical Imaging
5750 Hellyer Ave.
San Jose,  CA  95138
Applicant Contact JIM LENG
Correspondent
Nds Surgical Imaging
5750 Hellyer Ave.
San Jose,  CA  95138
Correspondent Contact JIM LENG
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/25/2013
Decision Date 02/28/2014
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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