The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Epidural Catheter With Connector (and Accessory).
| Device ID | K010425 |
| 510k Number | K010425 |
| Device Name: | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | Earl Smart |
| Correspondent | Earl Smart HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-13 |
| Decision Date | 2001-03-15 |