The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light.
| Device ID | K113279 |
| 510k Number | K113279 |
| Device Name: | IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT |
| Classification | Material, Impression |
| Applicant | KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg, DE 35713 |
| Contact | Simone Matuschka |
| Correspondent | Norbert Stuiber 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 | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-11-07 |
| Decision Date | 2011-11-14 |
| Summary: | summary |