The following data is part of a premarket notification filed by Normed Medizin-technik Gmbh with the FDA for Normed Titanium Miniplate System.
| Device ID | K931539 |
| 510k Number | K931539 |
| Device Name: | NORMED TITANIUM MINIPLATE SYSTEM |
| Classification | Plate, Bone |
| Applicant | NORMED MEDIZIN-TECHNIK GMBH 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Contact | Andrew E Taylor |
| Correspondent | Andrew E Taylor NORMED MEDIZIN-TECHNIK GMBH 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-29 |
| Decision Date | 1994-07-05 |