The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Insulin Syringe.
Device ID | K024112 |
510k Number | K024112 |
Device Name: | BD INSULIN SYRINGE |
Classification | Syringe, Piston |
Applicant | BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | John A Schalago |
Correspondent | John A Schalago BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-13 |
Decision Date | 2003-01-09 |
Summary: | summary |