The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Interlink(tm) Lever/y Lock.
Device ID | K940697 |
510k Number | K940697 |
Device Name: | BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK |
Classification | Set, Administration, Intravascular |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | Russell J Arnsberger |
Correspondent | Russell J Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-16 |
Decision Date | 1994-08-30 |