The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Core Biopsy Needle, Catalog Code #54006.
| Device ID | K891537 |
| 510k Number | K891537 |
| Device Name: | CORE BIOPSY NEEDLE, CATALOG CODE #54006 |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Robert E Jankun |
| Correspondent | Robert E Jankun DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-04-18 |