The following data is part of a premarket notification filed by Austenal, Inc. with the FDA for Dc Titan.
| Device ID | K001798 |
| 510k Number | K001798 |
| Device Name: | DC TITAN |
| Classification | Alloy, Metal, Base |
| Applicant | AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
| Contact | Ronald Dudek |
| Correspondent | Ronald Dudek AUSTENAL, INC. 4101 WEST 51ST ST. Chicago, IL 60632 -4287 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-14 |
| Decision Date | 2000-07-31 |