FDA 510(k) Application Details - K182003

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K182003
Device Name	Sleeve, Limb, Compressible
Applicant	Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek 3004200 IL Other 510(k) Applications for this Company
Contact	Reuven Yunger Other 510(k) Applications for this Contact
Regulation Number	870.5800   More FDA Info for this Regulation Number
Classification Product Code	JOW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2018
Decision Date	02/27/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review