The following data is part of a premarket notification filed by Silicon-und Composite Spezialitaten Gmbh with the FDA for Tray-link.
| Device ID | K992001 |
| 510k Number | K992001 |
| Device Name: | TRAY-LINK |
| Classification | Material, Impression |
| Applicant | SILICON-UND COMPOSITE SPEZIALITATEN GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Contact | Jurgen Engelbrecht |
| Correspondent | Jurgen Engelbrecht SILICON-UND COMPOSITE SPEZIALITATEN GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-15 |
| Decision Date | 1999-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519021302 | K992001 | 000 |
| 00850362007021 | K992001 | 000 |
| D7797031TA0 | K992001 | 000 |
| 00889813002391 | K992001 | 000 |