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FDA 510(k) Application Details - K060054
Device Classification Name
Low Energy Direct Current Thermal Ablation System
More FDA Info for this Device
510(K) Number
K060054
Device Name
Low Energy Direct Current Thermal Ablation System
Applicant
ONCOBIONICS, INC.
1700 PENNSYLVANIA AVENUE, NW
WASHINGTON, DC 20006 US
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Contact
LAURIE A CLARKE
Other 510(k) Applications for this Contact
Regulation Number
878.4400
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Classification Product Code
OAB
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More FDA Info for this Product Code
Date Received
01/06/2006
Decision Date
11/21/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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