510(k) Premarket Notification

• Device Classification Name: sleeve, limb, compressible
• 510(K) Number: K112677
• Model: DVT-2600
• Device Name: THE VENOUS ASSIST SYSTEM
• Applicant: DAESUNG MAREF CO., LTD.; 4568 west 1st street; suite 104; los angeles, CA 90004
• Contact: daniel nam
• Regulation Number: 870.5800
• Classification Product Code: JOW
• Date Received: 09/14/2011
• Decision Date: 01/13/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No