The following data is part of a premarket notification filed by Talladium, Inc. with the FDA for Talladium Tilite Ceramic Alloy.
| Device ID | K894085 |
| 510k Number | K894085 |
| Device Name: | TALLADIUM TILITE CERAMIC ALLOY |
| Classification | Alloy, Metal, Base |
| Applicant | TALLADIUM, INC. 25031 ANZA DR. Valencia, CA 91355 |
| Contact | Edward J Harms |
| Correspondent | Edward J Harms TALLADIUM, INC. 25031 ANZA DR. Valencia, CA 91355 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-08 |
| Decision Date | 1989-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D791252280 | K894085 | 000 |
| D7911240 | K894085 | 000 |
| D7911220 | K894085 | 000 |
| D7911110 | K894085 | 000 |
| D7911020 | K894085 | 000 |
| D7911010 | K894085 | 000 |
| D7911000 | K894085 | 000 |
| D79111105 | K894085 | 000 |
| D79110205 | K894085 | 000 |
| D79110105 | K894085 | 000 |
| D7911360 | K894085 | 000 |
| D7911910 | K894085 | 000 |
| D791252270 | K894085 | 000 |
| D791252260 | K894085 | 000 |
| D791252250 | K894085 | 000 |
| D791252240 | K894085 | 000 |
| D791252230 | K894085 | 000 |
| D791252220 | K894085 | 000 |
| D791210 | K894085 | 000 |
| D791200 | K894085 | 000 |
| D79119150 | K894085 | 000 |
| D79110005 | K894085 | 000 |