The following data is part of a premarket notification filed by Hans Hermann Gmbh with the FDA for The Titanium Miniplating System, The Titanium Microplating System, The Titanium Mediumplating System, Model #'s H12-1010.
| Device ID | K983535 |
| 510k Number | K983535 |
| Device Name: | THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010 |
| Classification | Plate, Bone |
| Applicant | HANS HERMANN GMBH UNTERER WINKEL 3 Wurmlingen, DE D-78567 |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser HANS HERMANN GMBH UNTERER WINKEL 3 Wurmlingen, DE D-78567 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1998-12-29 |