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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 K003330
Device Name AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)
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 Received10/24/2000
Decision Date 01/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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