The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for 0.9% Sodium Chloride Injection, Usp Bd Pre-filled Flush Syringe.
| Device ID | K003553 |
| 510k Number | K003553 |
| Device Name: | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DRIVE, BLDG 2, MAIL CODE 226 Franklin Lakes, NJ 07417 |
| Contact | Gregory W Morgan |
| Correspondent | Gregory W Morgan BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DRIVE, BLDG 2, MAIL CODE 226 Franklin Lakes, NJ 07417 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-03-21 |