The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Breast Lesion Localization Needle.
| Device ID | K881697 |
| 510k Number | K881697 |
| Device Name: | BREAST LESION LOCALIZATION NEEDLE |
| Classification | System, X-ray, Mammographic |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | J Arnsberger |
| Correspondent | J Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1988-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382904094091 | K881697 | 000 |
| 50382904094084 | K881697 | 000 |
| 50382904094077 | K881697 | 000 |