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FDA 510(k) Application Details - K160936
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K160936
Device Name
System, Ablation, Microwave And Accessories
Applicant
NEUWAVE MEDICAL, INC
3529 ANDERSON STREET
MADISON, WI 53704 US
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Contact
DAN KOSEDNAR
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
NEY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/04/2016
Decision Date
05/04/2016
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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