FDA 510(k) Application Details - K190975

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K190975
Device Name	Sleeve, Limb, Compressible
Applicant	Midway Medical, LLC. 3004 Gill Street Bloomington, IL 61704 US Other 510(k) Applications for this Company
Contact	Jim Tobin 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	04/15/2019
Decision Date	07/22/2019
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