The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Blunt Plastic Cannula.
Device ID | K974363 |
510k Number | K974363 |
Device Name: | BECTON DICKINSON BLUNT PLASTIC CANNULA |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | Gregory W Morgan |
Correspondent | Gregory W Morgan BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 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 | 1997-11-19 |
Decision Date | 1998-06-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903033800 | K974363 | 000 |
50382903033480 | K974363 | 000 |
50382903033473 | K974363 | 000 |
50382903033466 | K974363 | 000 |
50382903033459 | K974363 | 000 |
00382903033805 | K974363 | 000 |
30382903033806 | K974363 | 000 |