The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Eclipse Bifurcated Needle.
| Device ID | K032528 |
| 510k Number | K032528 |
| Device Name: | BD ECLIPSE BIFURCATED NEEDLE |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | Peter Zurlo |
| Correspondent | Peter Zurlo BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-15 |
| Decision Date | 2003-09-09 |