The following data is part of a premarket notification filed by Ssgi Prowess Systems with the FDA for Prowess Pro-sim.
| Device ID | K980379 |
| 510k Number | K980379 |
| Device Name: | PROWESS PRO-SIM |
| Classification | Accelerator, Linear, Medical |
| Applicant | SSGI PROWESS SYSTEMS 1370 RIDGEWOOD DR., #20 Chico, CA 95973 -7803 |
| Contact | Thomas A Boone |
| Correspondent | Thomas A Boone SSGI PROWESS SYSTEMS 1370 RIDGEWOOD DR., #20 Chico, CA 95973 -7803 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-30 |
| Decision Date | 1998-05-18 |
| Summary: | summary |