FDA 510(k) Application Details - K214053

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K214053
Device Name	Sleeve, Limb, Compressible
Applicant	Mego Afek AC Ltd. Kibbuts Afek Kibbuts Afek 3004200 IL Other 510(k) Applications for this Company
Contact	Ilan Sharon 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	12/27/2021
Decision Date	04/14/2022
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