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FDA 510(k) Application Details - K080202
Device Classification Name
Low Energy Direct Current Thermal Ablation System
More FDA Info for this Device
510(K) Number
K080202
Device Name
Low Energy Direct Current Thermal Ablation System
Applicant
ONCOBIONICS, INC.
30211 AVENIDA DE LAS BANDERAS
SUITE 200
RANCHO SANTA MARGARITA, CA 92679 US
Other 510(k) Applications for this Company
Contact
PAUL MIKUS
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
OAB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/28/2008
Decision Date
05/08/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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