FDA 510(k) Application Details - K191202

Device Classification Name	More FDA Info for this Device
510(K) Number	K191202
Device Name	CAPENERGY - C100, C200, C300, C400, C50
Applicant	Capenergy Medical SL Avinguda Mare de Deu de Montserrat, 41 Sant Joan Despi, Barcelona 08970 ES Other 510(k) Applications for this Company
Contact	Pilar Sanchez Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2019
Decision Date	02/11/2020
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