FDA 510(k) Application Details - K220981

Device Classification Name	Dilator, Vessel, Surgical   More FDA Info for this Device
510(K) Number	K220981
Device Name	Dilator, Vessel, Surgical
Applicant	Fehling Surgical Instruments, Inc. 1690 Stone Village Lane STE 721 Kennesaw, GA 30152 US Other 510(k) Applications for this Company
Contact	Hayden Hosch Other 510(k) Applications for this Contact
Regulation Number	870.4475   More FDA Info for this Regulation Number
Classification Product Code	DWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2022
Decision Date	04/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review