FDA 510(k) Application Details - K143438

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K143438
Device Name	Sleeve, Limb, Compressible
Applicant	Getinge (Suzhou) Co., Ltd No. 158 Fangzhou Road Suzhou 215024 TW Other 510(k) Applications for this Company
Contact	Lenda Hou 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	12/02/2014
Decision Date	06/23/2015
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