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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K081112
Device Name FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM
Applicant
Isodose Control B.V.
Landjuweel 11
Veenendaal,  NL 3905 PE
Applicant Contact HUB VAN DE BERGH
Correspondent
Isodose Control B.V.
Landjuweel 11
Veenendaal,  NL 3905 PE
Correspondent Contact HUB VAN DE BERGH
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received04/18/2008
Decision Date 07/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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