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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 K080376
Device Name ONCOBIONIC SYSTEM
Applicant
Oncobionic Incorporated
30211 Avenida De Las Banderas, Suite 200
Rancho Santa Margarita,  CA  92688
Applicant Contact PAUL MIKUS
Correspondent
Oncobionic Incorporated
30211 Avenida De Las Banderas, Suite 200
Rancho Santa Margarita,  CA  92688
Correspondent Contact PAUL MIKUS
Regulation Number878.4400
Classification Product Code
OAB  
Date Received02/12/2008
Decision Date 04/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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