The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Futar (futar, Futar D, Futar D Fast, Futar D Slow, Futar Scan Bite Registration Materials.
| Device ID | K081120 |
| 510k Number | K081120 |
| Device Name: | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS |
| 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 | 2008-04-21 |
| Decision Date | 2008-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205031662 | K081120 | 000 |
| E21728275111 | K081120 | 000 |
| E21728276111 | K081120 | 000 |
| E21728277111 | K081120 | 000 |
| E21728278111 | K081120 | 000 |
| E21728279111 | K081120 | 000 |
| E217119081 | K081120 | 000 |
| E217119121 | K081120 | 000 |
| E217119181 | K081120 | 000 |
| E21711975111 | K081120 | 000 |
| E21711961111 | K081120 | 000 |
| E21711923111 | K081120 | 000 |
| E2171192411 | K081120 | 000 |
| 00883205032430 | K081120 | 000 |
| E21711912111 | K081120 | 000 |
| E21711926111 | K081120 | 000 |
| E21711932111 | K081120 | 000 |
| E21711940111 | K081120 | 000 |
| E21711951111 | K081120 | 000 |
| E217119251 | K081120 | 000 |
| E217119261 | K081120 | 000 |
| E217119271 | K081120 | 000 |
| E217119751 | K081120 | 000 |
| E21711976 | K081120 | 000 |
| E217119761 | K081120 | 000 |
| E217282751 | K081120 | 000 |
| E217282761 | K081120 | 000 |
| E217282771 | K081120 | 000 |
| E217282781 | K081120 | 000 |
| E217282791 | K081120 | 000 |
| E217119711 | K081120 | 000 |
| E217119701 | K081120 | 000 |
| E217119281 | K081120 | 000 |
| E217119321 | K081120 | 000 |
| E217119391 | K081120 | 000 |
| E217119401 | K081120 | 000 |
| E217119511 | K081120 | 000 |
| E217119601 | K081120 | 000 |
| E217119611 | K081120 | 000 |
| E217119671 | K081120 | 000 |
| 00883205105356 | K081120 | 000 |