BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes And Length Assessment Device

System, Applicator, Radionuclide, Remote-controlled

Varian Medical Systems Inc.

The following data is part of a premarket notification filed by Varian Medical Systems Inc. with the FDA for Bravos Afterloader Family: Bravos Afterloader System, Transfer Guide Tubes And Length Assessment Device.

Pre-market Notification Details

Device IDK221797
510k NumberK221797
Device Name:BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes And Length Assessment Device
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant Varian Medical Systems Inc. 3100 Hansen Way, M/S/E-110 Palo Alto,  CA  94304
ContactPeter J. Coronado
CorrespondentPeter J. Coronado
Varian Medical Systems Inc. 3100 Hansen Way, M/S/E-110 Palo Alto,  CA  94304
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-21
Decision Date2022-09-14

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