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FDA 510(k) Application Details - K200061
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K200061
Device Name
System, Ablation, Microwave And Accessories
Applicant
Galil Medical Inc.
4364 Round Lake Road
Arden Hills, MN 55112 US
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Contact
Amy Mckinney
Other 510(k) Applications for this Contact
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
01/13/2020
Decision Date
07/09/2020
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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