The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Ultra-vue Spinal Type Biopsy Needle.
| Device ID | K862610 |
| 510k Number | K862610 |
| Device Name: | ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | R. J Arnsberger |
| Correspondent | R. J Arnsberger 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 | 1986-07-08 |
| Decision Date | 1987-02-04 |