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FDA 510(k) Application Details - K223138
Device Classification Name
System, Ablation, Microwave And Accessories
More FDA Info for this Device
510(K) Number
K223138
Device Name
System, Ablation, Microwave And Accessories
Applicant
Creo Medical Ltd.
Creo House, Unit 2, Beaufort Park Way
Chepstow NP16 5UH UA
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Contact
Tiffany Powell
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
10/04/2022
Decision Date
06/26/2023
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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