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FDA 510(k) Application Details - K200003
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K200003
Device Name
System, Ablation, Microwave And Accessories
Applicant
Creo Medical Ltd.
Creo House, Unit 2, Beaufort Park Way
Chepstow NP16 5UH GB
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Contact
Shaun Preston
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
01/02/2020
Decision Date
10/28/2020
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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