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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 K081935
Device Name STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100
Applicant
Aktina Medical Physics Corp.
360 N. Route 9w
Congers,  NY  10920
Applicant Contact TONY SPACCAROTELLA
Correspondent
Aktina Medical Physics Corp.
360 N. Route 9w
Congers,  NY  10920
Correspondent Contact TONY SPACCAROTELLA
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/07/2008
Decision Date 10/07/2008
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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