Interstitial Needles

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 Interstitial Needles.

Pre-market Notification Details

Device IDK160815
510k NumberK160815
Device Name:Interstitial Needles
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto,  CA  94304
ContactPeter J. Coronado
CorrespondentPeter J. Coronado
VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto,  CA  94304
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-24
Decision Date2017-03-10
Summary:summary

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