The following data is part of a premarket notification filed by M.i.s. Implants Technologies Ltd. with the FDA for Mis Implant System Decive.
| Device ID | K003191 |
| 510k Number | K003191 |
| Device Name: | MIS IMPLANT SYSTEM DECIVE |
| Classification | Implant, Endosseous, Root-form |
| Applicant | M.I.S. IMPLANTS TECHNOLOGIES LTD. BEIT HAPA'AMON, SUITE 206 BOX 124;20 HATA'AS ST. Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein M.I.S. IMPLANTS TECHNOLOGIES LTD. BEIT HAPA'AMON, SUITE 206 BOX 124;20 HATA'AS ST. Kfar Saba, IL 44425 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2001-09-28 |