The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Blunt Steel Cannula.
Device ID | K944931 |
510k Number | K944931 |
Device Name: | BECTON DICKINSON BLUNT STEEL CANNULA |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DRIVE, BLDG 2, MAIL CODE 226 Franklin Lakes, NJ 07417 |
Contact | Greg W Morgan |
Correspondent | Greg W Morgan BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DRIVE, BLDG 2, MAIL CODE 226 Franklin Lakes, NJ 07417 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-06 |
Decision Date | 1995-08-29 |