FDA 510(k) Application Details - K213247

Device Classification Name	More FDA Info for this Device
510(K) Number	K213247
Device Name	JETT PLASMA Medical II
Applicant	Compex, Spol. s.r.o Palackeho Trida 924/105 Brno 61200 CZ Other 510(k) Applications for this Company
Contact	Eva Hamplova Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2021
Decision Date	03/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review