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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 K971893
Device Name SNT LINAC ACCESSORIES
Applicant
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Applicant Contact ROGER N WHITE
Correspondent
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Correspondent Contact ROGER N WHITE
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/22/1997
Decision Date 11/13/1997
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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