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FDA 510(k) Application Details - K061865
Device Classification Name
System, Ablation, Microwave And Accessories
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510(K) Number
K061865
Device Name
System, Ablation, Microwave And Accessories
Applicant
GUIDANT CORP.
3200 LAKESIDE DR.
SANTA CLARA, CA 95054 US
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Contact
CHRISTINA L LOWE
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Regulation Number
878.4400
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Classification Product Code
NEY
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More FDA Info for this Product Code
Date Received
07/03/2006
Decision Date
07/27/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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