FDA 510(k) Application Details - K191107

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K191107
Device Name	Sleeve, Limb, Compressible
Applicant	Alleva Medical (D.G.) Ltd Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan Street Hong Kong HK Other 510(k) Applications for this Company
Contact	Max Choi 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	04/26/2019
Decision Date	08/27/2019
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