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FDA 510(k) Application Details - K240518
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K240518
Device Name
System, Ablation, Microwave And Accessories
Applicant
Emblation Limited
Emblation House
Castle Business Park
Stirling FK9 4TS GB
Other 510(k) Applications for this Company
Contact
Mairi MacFadyen
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
02/23/2024
Decision Date
04/23/2024
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
FDA Source Information for K240518
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