The following data is part of a premarket notification filed by Medxpert Gmbh with the FDA for Medxpert P.e.s. (pectus Exacvatum System), Medxpert Stratos.
| Device ID | K073556 |
| 510k Number | K073556 |
| Device Name: | MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS |
| Classification | Plate, Fixation, Bone |
| Applicant | MEDXPERT GMBH GRIESWEG 47 Muhlheim, Baden-wurttemberg, DE 78570 |
| Contact | Franz Menean |
| Correspondent | Franz Menean MEDXPERT GMBH GRIESWEG 47 Muhlheim, Baden-wurttemberg, DE 78570 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-19 |
| Decision Date | 2008-06-24 |
| Summary: | summary |