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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 K964840
Device Name BEAM BLOCK TRAYS
Applicant
Aktina Medical Physics Corp.
360 N. Rte. 9w
Congers,  NY  10920
Applicant Contact JOAN ZACHAROPOULOS
Correspondent
Aktina Medical Physics Corp.
360 N. Rte. 9w
Congers,  NY  10920
Correspondent Contact JOAN ZACHAROPOULOS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/29/1996
Decision Date 02/11/1997
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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