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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K994355
Device Name RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
Applicant
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Applicant Contact ANGELIQUE S DESTRUEL
Correspondent
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Correspondent Contact ANGELIQUE S DESTRUEL
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/23/1999
Decision Date 03/22/2000
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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