510(k) Premarket Notification

• Device Classification Name: needle, hypodermic, single lumen
• 510(K) Number: K122249
• Device Name: TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
• Applicant: TERUMO (PHILIPPINES) CORPORATION; 950 elkton blvd; elkton, MD 21921
• Contact: phillip lester
• Regulation Number: 880.5570
• Classification Product Code: FMI
• Subsequent Product Code: MEG
• Date Received: 07/30/2012
• Decision Date: 08/28/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General Hospital
• Review Advisory Committee: General Hospital
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No