The following data is part of a premarket notification filed by Mondeal Medical Systems Gmbh with the FDA for Sis Sinus Implant Stabilizer.
| Device ID | K062436 |
| 510k Number | K062436 |
| Device Name: | SIS SINUS IMPLANT STABILIZER |
| Classification | Plate, Bone |
| Applicant | MONDEAL MEDICAL SYSTEMS GMBH AMSTEL 320-1 Amsterdam, NL 1017ap |
| Contact | Angelika Scherp |
| Correspondent | Angelika Scherp MONDEAL MEDICAL SYSTEMS GMBH AMSTEL 320-1 Amsterdam, NL 1017ap |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-21 |
| Decision Date | 2007-07-30 |
| Summary: | summary |