The following data is part of a premarket notification filed by Mondeal Medical Systems Gmbh with the FDA for Mondeal Hand Contour System.
| Device ID | K071797 |
| 510k Number | K071797 |
| Device Name: | MONDEAL HAND CONTOUR SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | MONDEAL MEDICAL SYSTEMS GMBH 13566 FREEPORT ROAD San Diego, CA 92133 |
| Contact | Jay Evans |
| Correspondent | Jay Evans MONDEAL MEDICAL SYSTEMS GMBH 13566 FREEPORT ROAD San Diego, CA 92133 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-09-17 |
| Summary: | summary |