FDA 510(k) Application Details - K121001

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K121001
Device Name	Sleeve, Limb, Compressible
Applicant	NOVITAS MEDICAL, LLC 451 WEST LAMBERT ROAD SUITE 209 BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	MARSHAL FRYMAN 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	04/02/2012
Decision Date	04/17/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review