The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Vacutainer Safety-lok Administration Set With Filter.
| Device ID | K033350 |
| 510k Number | K033350 |
| Device Name: | BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER |
| Classification | Set, Administration, Intravascular |
| Applicant | BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
| Contact | M. Wendy Ballesteros |
| Correspondent | M. Wendy Ballesteros BECTON DICKINSON & CO. 1 Becton Drive Franklin Lakes, NJ 07417 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-20 |
| Decision Date | 2003-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904726004 | K033350 | 000 |