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510(k) Data Aggregation
K Number
K080376Device Name
ONCOBIONIC SYSTEM
Manufacturer
ONCOBIONIC INCORPORATED
Date Cleared
2008-04-02
(50 days)
Product Code
OAB
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ONCOBIONIC INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oncobionic System is indicated for surgical ablation of soft tissuc
Device Description
The Oncobionic System includes additional treatment parameters. These additional treatment parameters allow for the application of the Oncobionic System to target and ablate additional volumes of soft tissue. The Oncobionic System with additional treatment parameters applies a I .EDC pulse or series of pulses between two clectrodes to cause an ablation clicel to occur. The fundamental application and design of the device has not changed, but new treatment parameters have been tested and added to the device to cause additional volumes of soft tissue ablation
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