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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K251037
Device Name Rectal Applicator
Applicant
Nucletron B.V.
3900 Ax Veenendaal, P.O. Box 930
Waardgelder 1
Veenendaal,  NL 3905TH
Applicant Contact Loes Vloet-Emonts
Correspondent
Nucletron B.V.
3900 Ax Veenendaal, P.O. Box 930
Waardgelder 1
Veenendaal,  NL 3905TH
Correspondent Contact Loes Vloet-Emonts
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received04/03/2025
Decision Date 12/19/2025
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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