FDA 510(k) Application Details - K094021

Device Classification Name System, Ablation, Microwave And Accessories

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510(K) Number K094021
Device Name System, Ablation, Microwave And Accessories
Applicant MICROSULIS MEDICAL LIMITED
UNITS 1 & 2 FALCON COURT
PARKLANDS BUSINESS PARK
DENMEAD HAMPSHIRE PO7 6XP GB
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Contact DENISE REXHAUS
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Regulation Number 878.4400

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Classification Product Code NEY
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Date Received 12/30/2009
Decision Date 08/06/2010
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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