The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Piston Syringes.
| Device ID | K944757 |
| 510k Number | K944757 |
| Device Name: | PISTON SYRINGES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 2350 Qume Dr. San Jose, CA 95131 |
| Contact | Karen Rosencrans |
| Correspondent | Karen Rosencrans BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 2350 Qume Dr. San Jose, CA 95131 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1995-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903096065 | K944757 | 000 |
| 50382903055543 | K944757 | 000 |
| 50382903055581 | K944757 | 000 |
| 50382903055598 | K944757 | 000 |
| 50382903055611 | K944757 | 000 |
| 50382903055642 | K944757 | 000 |
| 50382903095921 | K944757 | 000 |
| 50382903095938 | K944757 | 000 |
| 50382903095945 | K944757 | 000 |
| 50382903095952 | K944757 | 000 |
| 50382903095969 | K944757 | 000 |
| 50382903055536 | K944757 | 000 |