The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Preset Blood Collection Syringe, Bd A-line Blood Collection Syringe, Models 365313, 365323,365316,365356,365373,36538.
| Device ID | K022426 |
| 510k Number | K022426 |
| Device Name: | BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | M. Wendy Bosshardt |
| Correspondent | M. Wendy Bosshardt BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-25 |
| Decision Date | 2002-08-08 |
| Summary: | summary |