The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Safetyglide Needle.
| Device ID | K951254 |
| 510k Number | K951254 |
| Device Name: | SAFETYGLIDE NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Karen L Rosencrans |
| Correspondent | Karen L Rosencrans BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE 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 | 1995-03-21 |
| Decision Date | 1995-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903059275 | K951254 | 000 |
| 40612479248791 | K951254 | 000 |
| 40612479248784 | K951254 | 000 |
| 40612479248777 | K951254 | 000 |
| 40612479248739 | K951254 | 000 |
| 20612479262601 | K951254 | 000 |
| 20612479262571 | K951254 | 000 |
| 20612479262540 | K951254 | 000 |
| 20612479262519 | K951254 | 000 |
| 20612479262489 | K951254 | 000 |
| 20612479262458 | K951254 | 000 |
| 20612479262427 | K951254 | 000 |
| 50382903043878 | K951254 | 000 |
| 30382903033301 | K951254 | 000 |
| 00382903033270 | K951254 | 000 |
| 40612479248807 | K951254 | 000 |
| 40612479248814 | K951254 | 000 |
| 50382903059213 | K951254 | 000 |
| 50382903059183 | K951254 | 000 |
| 50382903059176 | K951254 | 000 |
| 50382903059169 | K951254 | 000 |
| 50382903059152 | K951254 | 000 |
| 50382903059039 | K951254 | 000 |
| 50382903059022 | K951254 | 000 |
| 50382903059015 | K951254 | 000 |
| 50382903059008 | K951254 | 000 |
| 10889942173808 | K951254 | 000 |
| 50884908093686 | K951254 | 000 |
| 50884908090654 | K951254 | 000 |
| 40612479248838 | K951254 | 000 |
| 40612479248821 | K951254 | 000 |
| 50382903033268 | K951254 | 000 |