FDA 510(k) Application Details - K241764

Device Classification Name System, Applicator, Radionuclide, Remote-Controlled

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510(K) Number K241764
Device Name System, Applicator, Radionuclide, Remote-Controlled
Applicant Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto, CA 94304 US
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Contact Lynn Allman
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Regulation Number 892.5700

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Classification Product Code JAQ
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Date Received 06/20/2024
Decision Date 01/10/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241764


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