The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Carbon Fiber Breast Board.
| Device ID | K974703 |
| 510k Number | K974703 |
| Device Name: | CARBON FIBER BREAST BOARD |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
| Contact | Donald F Ribe |
| Correspondent | Donald F Ribe MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 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 | 1997-12-16 |
| Decision Date | 1998-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439110720 | K974703 | 000 |
| 00841439102589 | K974703 | 000 |
| 00841439102572 | K974703 | 000 |
| 00841439102558 | K974703 | 000 |
| 00841439102541 | K974703 | 000 |
| 00841439111383 | K974703 | 000 |
| 00841439102695 | K974703 | 000 |
| 00841439102640 | K974703 | 000 |
| 00841439102565 | K974703 | 000 |
| 00841439102602 | K974703 | 000 |
| 00841439102657 | K974703 | 000 |
| 00841439102664 | K974703 | 000 |
| 00841439110676 | K974703 | 000 |
| 00841439110553 | K974703 | 000 |
| 00841439104347 | K974703 | 000 |
| 00841439104330 | K974703 | 000 |
| 00841439102725 | K974703 | 000 |
| 00841439102718 | K974703 | 000 |
| 00841439102701 | K974703 | 000 |
| 00841439102671 | K974703 | 000 |
| 00841439102688 | K974703 | 000 |