The following data is part of a premarket notification filed by Jamieson Film Co. with the FDA for Cap-35b Iii/cine 275.
| Device ID | K971128 |
| 510k Number | K971128 |
| Device Name: | CAP-35B III/CINE 275 |
| Classification | Table, Radiographic, Tilting |
| Applicant | JAMIESON FILM CO. 10425 OLYMPIC DR. Dallas, TX 75220 -4427 |
| Contact | Gary W Fuller |
| Correspondent | Gary W Fuller JAMIESON FILM CO. 10425 OLYMPIC DR. Dallas, TX 75220 -4427 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-27 |
| Decision Date | 1997-04-28 |
| Summary: | summary |