The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Breast Les Local Wire St. 48219/49220/48119/48120.
| Device ID | K914608 |
| 510k Number | K914608 |
| Device Name: | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Roger W Brink |
| Correspondent | Roger W Brink DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-17 |
| Decision Date | 1992-01-09 |