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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 K060054
Device Name ONCOBIONIC SYSTEM
Applicant
ONCOBIONICS, INC.
1700 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Applicant Contact LAURIE A CLARKE
Correspondent
ONCOBIONICS, INC.
1700 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Correspondent Contact LAURIE A CLARKE
Regulation Number878.4400
Classification Product Code
OAB  
Subsequent Product Code
OCL  
Date Received01/06/2006
Decision Date 11/21/2006
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
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