FDA 510(k) Application Details - K162481

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K162481
Device Name	Sleeve, Limb, Compressible
Applicant	RECOVERY FORCE LLC 12175 VISIONARY WAY, SUITE 540 FISHERS, IN 46038 US Other 510(k) Applications for this Company
Contact	Jeff Schwegman 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	09/06/2016
Decision Date	02/16/2017
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