The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Syringe Nrfit Lok And Bd Syringe Nrfit Slip.
| Device ID | K192538 |
| 510k Number | K192538 |
| Device Name: | BD Syringe NRFit Lok And BD Syringe NRFit Slip |
| Classification | Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/or Indirect Cerebral Spinal Fluid Contact |
| Applicant | Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | Murtaza Rana |
| Correspondent | Murtaza Rana Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | QEH |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2020-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382904001839 | K192538 | 000 |
| 50382904001822 | K192538 | 000 |
| 50382904001754 | K192538 | 000 |
| 30382904001743 | K192538 | 000 |
| 50382904001730 | K192538 | 000 |
| 50382904001723 | K192538 | 000 |
| 50382904000511 | K192538 | 000 |
| 50382904000504 | K192538 | 000 |