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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Energy Direct Current Thermal Ablation System
510(k) Number K080202
Device Name ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
Applicant
ONCOBIONICS, INC.
30211 AVENIDA DE LAS BANDERAS
SUITE 200
RANCHO SANTA MARGARITA,  CA  92679
Applicant Contact PAUL MIKUS
Correspondent
ONCOBIONICS, INC.
30211 AVENIDA DE LAS BANDERAS
SUITE 200
RANCHO SANTA MARGARITA,  CA  92679
Correspondent Contact PAUL MIKUS
Regulation Number878.4400
Classification Product Code
OAB  
Date Received01/28/2008
Decision Date 05/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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