The following data is part of a premarket notification filed by Comet Ltd. C/o Radiology Resources, Inc. with the FDA for Telamat.
| Device ID | K864749 |
| 510k Number | K864749 |
| Device Name: | TELAMAT |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | COMET LTD. C/O RADIOLOGY RESOURCES, INC. 4 DRAPER ST. Worburn, MA 01801 |
| Contact | Charles E Moreland |
| Correspondent | Charles E Moreland COMET LTD. C/O RADIOLOGY RESOURCES, INC. 4 DRAPER ST. Worburn, MA 01801 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-05 |
| Decision Date | 1987-02-10 |