The following data is part of a premarket notification filed by Bd/preefil with the FDA for Bd Preefile Normal Saline Flush Syringe Flush Syringe.
| Device ID | K982558 |
| 510k Number | K982558 |
| Device Name: | BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BD/PREEFIL 1 BECTON DR. MC 226 Franklin Lakes, NJ 07417 |
| Contact | Greg Morgan |
| Correspondent | Greg Morgan BD/PREEFIL 1 BECTON DR. MC 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 | 1998-07-22 |
| Decision Date | 2000-03-08 |
| Summary: | summary |