The following data is part of a premarket notification filed by Engineering, Inc. with the FDA for Ls9000 Suction Biopsy Needle.
| Device ID | K862749 |
| 510k Number | K862749 |
| Device Name: | LS9000 SUCTION BIOPSY NEEDLE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | ENGINEERING, INC. 214 LINCOLN CENTER DR. Foster City, CA 94404 |
| Contact | Lash, Md |
| Correspondent | Lash, Md ENGINEERING, INC. 214 LINCOLN CENTER DR. Foster City, CA 94404 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-21 |
| Decision Date | 1986-09-15 |