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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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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