LEVEEN NEEDLE ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

RADIOTHERAPEUTICS CORP.

The following data is part of a premarket notification filed by Radiotherapeutics Corp. with the FDA for Leveen Needle Electrode.

Pre-market Notification Details

Device IDK982556
510k NumberK982556
Device Name:LEVEEN NEEDLE ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant RADIOTHERAPEUTICS CORP. 2685 MARINE WAY, SUITE 1408 Mountain View,  CA  94043
ContactColin J Nichols
CorrespondentColin J Nichols
RADIOTHERAPEUTICS CORP. 2685 MARINE WAY, SUITE 1408 Mountain View,  CA  94043
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-22
Decision Date2000-04-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.