The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Identium Heavy, Medium, Medium Soft, Light.
| Device ID | K092867 |
| 510k Number | K092867 |
| Device Name: | IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT |
| 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 | 2009-09-18 |
| Decision Date | 2009-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E217147271 | K092867 | 000 |
| E217147331 | K092867 | 000 |
| E21713701111 | K092867 | 000 |
| E21713711111 | K092867 | 000 |
| E217137001 | K092867 | 000 |
| E217137011 | K092867 | 000 |
| E217137101 | K092867 | 000 |
| E217137111 | K092867 | 000 |
| E217147161 | K092867 | 000 |
| E217147171 | K092867 | 000 |
| E217147181 | K092867 | 000 |
| E217147191 | K092867 | 000 |
| E217147241 | K092867 | 000 |
| E217147251 | K092867 | 000 |
| E217147261 | K092867 | 000 |
| E217147321 | K092867 | 000 |