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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 K141669
Device Name SURGIMAP
Applicant
Nemaris, Inc.
1425 K St., NW
11th Floor
Washington,  DC  20005
Applicant Contact KEITH BARRITT
Correspondent
Nemaris, Inc.
1425 K St., NW
11th Floor
Washington,  DC  20005
Correspondent Contact KEITH BARRITT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/23/2014
Decision Date 09/19/2014
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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