The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base Lock Replacement Kit.
| Device ID | K132908 |
| 510k Number | K132908 |
| Device Name: | TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDTEC, INC. 1401 8TH ST. S.E. Orange City, IA 51041 |
| Contact | Amanda Stahle |
| Correspondent | Amanda Stahle MEDTEC, INC. 1401 8TH ST. S.E. Orange City, IA 51041 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-17 |
| Decision Date | 2014-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841439104245 | K132908 | 000 |
| 10841439104221 | K132908 | 000 |
| 00841439111819 | K132908 | 000 |
| 00841439111802 | K132908 | 000 |
| 00841439104385 | K132908 | 000 |
| 00841439104217 | K132908 | 000 |
| 00841439104255 | K132908 | 000 |