The following data is part of a premarket notification filed by Bd with the FDA for Bd Bifurcated Needle, Models 301754, 301755, 301756, 301757.
| Device ID | K020523 |
| 510k Number | K020523 |
| Device Name: | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | BD ONE BECTON DRIVE MC226 Franklin Lakes, NJ 07417 |
| Contact | Pasquale Amoto |
| Correspondent | Pasquale Amoto BD ONE BECTON DRIVE MC226 Franklin Lakes, NJ 07417 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-19 |
| Decision Date | 2002-03-20 |
| Summary: | summary |