ONCOBIONIC SYSTEM

Low Energy Direct Current Thermal Ablation System

ONCOBIONIC INCORPORATED

The following data is part of a premarket notification filed by Oncobionic Incorporated with the FDA for Oncobionic System.

Pre-market Notification Details

Device IDK080376
510k NumberK080376
Device Name:ONCOBIONIC SYSTEM
ClassificationLow Energy Direct Current Thermal Ablation System
Applicant ONCOBIONIC INCORPORATED 30211 AVENIDA DE LAS BANDERAS SUITE 200 Rancho Santa Margarita,  CA  92688
ContactPaul Mikus
CorrespondentPaul Mikus
ONCOBIONIC INCORPORATED 30211 AVENIDA DE LAS BANDERAS SUITE 200 Rancho Santa Margarita,  CA  92688
Product CodeOAB  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-12
Decision Date2008-04-02
Summary:summary

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