The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Carbon Fiber Conformal Couch Top.
| Device ID | K973842 |
| 510k Number | K973842 |
| Device Name: | CARBON FIBER CONFORMAL COUCH TOP |
| Classification | Table, Radiographic, Stationary Top |
| Applicant | MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
| Contact | Donald F Riibe |
| Correspondent | Donald F Riibe MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
| Product Code | IXQ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-08 |
| Decision Date | 1997-12-05 |