The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Guardian Nestable Sharps Collectors.
| Device ID | K943575 |
| 510k Number | K943575 |
| Device Name: | B-D GUARDIAN NESTABLE SHARPS COLLECTORS |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Karen Rosencrans |
| Correspondent | Karen Rosencrans BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-22 |
| Decision Date | 1994-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903056651 | K943575 | 000 |
| 50382903050241 | K943575 | 000 |
| 50382903050258 | K943575 | 000 |
| 50382903050265 | K943575 | 000 |
| 50382903056663 | K943575 | 000 |
| 00382903056019 | K943575 | 000 |
| 00382903056026 | K943575 | 000 |
| 00382903056095 | K943575 | 000 |
| 00382903056101 | K943575 | 000 |
| 00382903056156 | K943575 | 000 |
| 50382903050234 | K943575 | 000 |