The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Accuplace (tm).
| Device ID | K904172 |
| 510k Number | K904172 |
| Device Name: | ACCUPLACE (TM) |
| Classification | Guide, Needle, Surgical |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Roger Brink |
| Correspondent | Roger Brink DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-11 |
| Decision Date | 1990-11-21 |