FDA 510(k) Application Details - K131420

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K131420
Device Name	Sleeve, Limb, Compressible
Applicant	MEGO AFEK AC LTD 55 NORTHERN BLVD., STE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	MARIA GRIFFIN 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	05/16/2013
Decision Date	11/01/2013
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