The following data is part of a premarket notification filed by Becton, Dickinson Company with the FDA for Bd Flowsmart Set.
Device ID | K150059 |
510k Number | K150059 |
Device Name: | BD FlowSmart Set |
Classification | Set, Administration, Intravascular |
Applicant | BECTON, DICKINSON COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07666 |
Contact | Avital Merl |
Correspondent | Avital Merl BECTON, DICKINSON COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07666 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-13 |
Decision Date | 2015-04-28 |
Summary: | summary |