The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Autoshield Duo Pen Needle.
| Device ID | K110703 |
| 510k Number | K110703 |
| Device Name: | BD AUTOSHIELD DUO PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Becton, Dickinson And Company 1 BECTON DRIVE MC 372 Franklin Lakes, NJ 07417 |
| Contact | Cynthia Lacatena |
| Correspondent | Cynthia Lacatena Becton, Dickinson And Company 1 BECTON DRIVE MC 372 Franklin Lakes, NJ 07417 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-14 |
| Decision Date | 2011-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903295154 | K110703 | 000 |