The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Models 54601/54602/54603/54604 Needle & Biopsy Kit.
| Device ID | K864329 |
| 510k Number | K864329 |
| Device Name: | MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT |
| Classification | Instrument, Biopsy |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Ronald Williams |
| Correspondent | Ronald Williams DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-04 |
| Decision Date | 1986-12-03 |