The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Interlink Vial Access Cannula.
Device ID | K924439 |
510k Number | K924439 |
Device Name: | BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | Russell J Arnsberge |
Correspondent | Russell J Arnsberge 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 | 1992-09-01 |
Decision Date | 1993-02-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903034050 | K924439 | 000 |
50382903034036 | K924439 | 000 |
50382903034012 | K924439 | 000 |
50382903033671 | K924439 | 000 |
30382903033776 | K924439 | 000 |