The following data is part of a premarket notification filed by Austenal, Inc. with the FDA for Vitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome Casting Alloy.
| Device ID | K970205 |
| 510k Number | K970205 |
| Device Name: | VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY |
| 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 | 1997-01-21 |
| Decision Date | 1997-04-21 |
| Summary: | summary |