510(k) Premarket Notification

• Device Classification Name: i.v. start kit
• 510(k) Number: K942238
• Device Name: I.V. STARTPAK VASCULAR ACCESS START KIT
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC; 9450 SOUTH STATE SREET; SANDY, UT 84070
• Applicant Contact: C.J. WELLE
• Correspondent: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC; 9450 SOUTH STATE SREET; SANDY, UT 84070
• Correspondent Contact: C.J. WELLE
• Regulation Number: 880.5200
• Classification Product Code: LRS
• Date Received: 05/09/1994
• Decision Date: 06/03/1994
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General & Plastic Surgery
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No