BECTON DICKINSON TWINPAK

Needle, Hypodermic, Single Lumen

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Twinpak.

Pre-market Notification Details

• Device ID: K974006
• 510k Number: K974006
• Device Name: BECTON DICKINSON TWINPAK
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880
• Contact: Greg Morgon
• Correspondent: Greg Morgon; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-10-21
• Decision Date: 1998-01-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50382903033930	K974006	000
50382903033923	K974006	000
50382903033916	K974006	000
50382903033909	K974006	000