FDA 510(k) Application Details - K223245

Device Classification Name	More FDA Info for this Device
510(K) Number	K223245
Device Name	Colibrφ
Applicant	Copan WASP Srl Via A. Grandi, 32 Brescia 25125 IT Other 510(k) Applications for this Company
Contact	Giovanna Catalano Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2022
Decision Date	03/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review