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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 K192102
Device Name Thermoplastic Masks
Applicant
Aktina Medical Corporation
360 N. Rte. 9w
Congers,  NY  10920
Applicant Contact Tony Spaccarotella
Correspondent
Aktina Medical Corporation
360 N. Rte. 9w
Congers,  NY  10920
Correspondent Contact Tony Spaccarotella
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/05/2019
Decision Date 09/25/2019
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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