The following data is part of a premarket notification filed by Bd with the FDA for 0.9% Sodium Chloride Injection, Usp Bd Pre-filled Flush Syringe.
| Device ID | K011982 |
| 510k Number | K011982 |
| 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 ONE BECTON DRIVE MC226 Franklin Lakes, NJ 07417 |
| Contact | Gregory W Morgan |
| Correspondent | Gregory W Morgan BD ONE BECTON DRIVE MC226 Franklin Lakes, NJ 07417 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-26 |
| Decision Date | 2001-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903065191 | K011982 | 000 |
| 50382903065184 | K011982 | 000 |
| 50382903065085 | K011982 | 000 |
| 50382903065078 | K011982 | 000 |
| 50382903065054 | K011982 | 000 |
| 50382903065047 | K011982 | 000 |
| 50382903065030 | K011982 | 000 |
| 50382903065023 | K011982 | 000 |
| 50382903065009 | K011982 | 000 |