The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Percutaneous Guidewire Placement Syringe 50505.
| Device ID | K855089 |
| 510k Number | K855089 |
| Device Name: | PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505 |
| Classification | Wire, Guide, Catheter |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Ronald A Williams |
| Correspondent | Ronald A Williams DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-20 |
| Decision Date | 1986-02-18 |