The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for 0.9% Sodium Chloride Injection, Usp Bd Posiflush Sf Syringe.
Device ID | K153481 |
510k Number | K153481 |
Device Name: | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe |
Classification | Saline, Vascular Access Flush |
Applicant | BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes, NJ 07417 |
Contact | John Blewitt |
Correspondent | John Blewitt BECTON, DICKINSON AND COMPANY 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 | 2015-12-03 |
Decision Date | 2016-04-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903065535 | K153481 | 000 |