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FDA 510(k) Application Details - K220472
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K220472
Device Name
System, Ablation, Microwave And Accessories
Applicant
NeuWave Medical Inc.
3529 Anderson Street
Madison, WI 53704 US
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Contact
Mohamed Shariff
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
02/18/2022
Decision Date
08/11/2022
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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