The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Hypoint Needle.
| Device ID | K070440 |
| 510k Number | K070440 |
| Device Name: | BD HYPOINT NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Aileen C Gilbert |
| Correspondent | Aileen C Gilbert BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-15 |
| Decision Date | 2007-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903013901 | K070440 | 000 |
| 50382903002646 | K070440 | 000 |
| 50382903002639 | K070440 | 000 |
| 50382903002554 | K070440 | 000 |
| 50382903002493 | K070440 | 000 |
| 50382903002080 | K070440 | 000 |
| 50382903002530 | K070440 | 000 |