The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Seldinger Safety Needle Introducer.
| Device ID | K032404 |
| 510k Number | K032404 |
| Device Name: | SELDINGER SAFETY NEEDLE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | HDC CORP. 628 GIBRALTAR CT. Milpitas, CA 95035 |
| Contact | Earl Smart |
| Correspondent | Earl Smart HDC CORP. 628 GIBRALTAR CT. Milpitas, CA 95035 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-09-10 |