The following data is part of a premarket notification filed by Mis - Implant Technologies Ltd. with the FDA for Mis Crest Widener.
| Device ID | K080458 |
| 510k Number | K080458 |
| Device Name: | MIS CREST WIDENER |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | MIS - IMPLANT TECHNOLOGIES LTD. POB 110 SHLOMI INDUSTRIAL ZONE Shlomi, IL 22832 |
| Contact | Iman Khorshid |
| Correspondent | Iman Khorshid MIS - IMPLANT TECHNOLOGIES LTD. POB 110 SHLOMI INDUSTRIAL ZONE Shlomi, IL 22832 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-20 |
| Decision Date | 2008-12-17 |
| Summary: | summary |