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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 K991468
Device Name IMMERGE IMAGE CORRELATION
Applicant
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Applicant Contact ROGER WHITE
Correspondent
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Correspondent Contact ROGER WHITE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/27/1999
Decision Date 07/06/1999
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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