The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Kettosil And Silginat.
| Device ID | K082157 |
| 510k Number | K082157 |
| Device Name: | KETTOSIL AND SILGINAT |
| Classification | Material, Impression |
| Applicant | KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg, DE 35713 |
| Contact | Michaela Zinke |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-31 |
| Decision Date | 2008-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E217147151 | K082157 | 000 |
| 00883205033703 | K082157 | 000 |
| 00883205033710 | K082157 | 000 |
| E21713826111 | K082157 | 000 |
| E21713827111 | K082157 | 000 |
| E21713846111 | K082157 | 000 |
| E21713847111 | K082157 | 000 |
| E217138261 | K082157 | 000 |
| E217138271 | K082157 | 000 |
| E217138461 | K082157 | 000 |
| E217138471 | K082157 | 000 |
| E217138481 | K082157 | 000 |
| E217147121 | K082157 | 000 |
| E217147131 | K082157 | 000 |
| E217147141 | K082157 | 000 |
| 00883205033697 | K082157 | 000 |