FDA 510(k) Application Details - K163620

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K163620
Device Name	Sleeve, Limb, Compressible
Applicant	Covidien 15 Hampshire Stree Mansfield, MA 02048 US Other 510(k) Applications for this Company
Contact	Nicole Genco 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	12/22/2016
Decision Date	01/19/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review