The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for 0.9% Sodium Chloride Injection Usp Bd Posiflush Flush Syringe, Sf Flush Syringe.
Device ID | K121050 |
510k Number | K121050 |
Device Name: | 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE |
Classification | Saline, Vascular Access Flush |
Applicant | BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
Contact | John Roberts |
Correspondent | John Roberts BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
Product Code | NGT |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-06 |
Decision Date | 2013-02-07 |
Summary: | summary |