FDA 510(k) Application Details - K183631

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K183631
Device Name	Sleeve, Limb, Compressible
Applicant	Medi USA, LP 6481 Franz Warner Pkwy. Whitsett, NC 27377 US Other 510(k) Applications for this Company
Contact	Glenn Anderson 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	12/26/2018
Decision Date	01/25/2019
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	Y
Expedited Review