FDA 510(k) Application Details - K200298

Device Classification Name	System, Ablation, Microwave And Accessories   More FDA Info for this Device
510(K) Number	K200298
Device Name	System, Ablation, Microwave And Accessories
Applicant	Creo Medical Ltd. Creo House, Unit 2, Beaufort Park Way Chepstow NP16 5UH GB Other 510(k) Applications for this Company
Contact	Patrick Burn 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	02/06/2020
Decision Date	01/05/2021
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