FDA 510(k) Application Details - K202919

Device Classification Name	Tourniquet, Pneumatic   More FDA Info for this Device
510(K) Number	K202919
Device Name	Tourniquet, Pneumatic
Applicant	McEwen and Associates Consulting Ltd. 207-1099 West 8th Avenue Vancouver V6H 1C3 CA Other 510(k) Applications for this Company
Contact	Julie Kerr Other 510(k) Applications for this Contact
Regulation Number	878.5910   More FDA Info for this Regulation Number
Classification Product Code	KCY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2020
Decision Date	05/20/2021
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