FDA 510(k) Application Details - K211207

Device Classification Name	More FDA Info for this Device
510(K) Number	K211207
Device Name	Diacare 7000
Applicant	Globus Sport and Health Technologies LLC 7280 NW 7th St # 109 Miami, FL 33126 US Other 510(k) Applications for this Company
Contact	Jorge Millan 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	04/22/2021
Decision Date	06/06/2022
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