The following data is part of a premarket notification filed by Besco Financial Service with the FDA for Regnell Hydraulic Femoral Prothesis.
| Device ID | K830285 |
| 510k Number | K830285 |
| Device Name: | REGNELL HYDRAULIC FEMORAL PROTHESIS |
| Classification | Assembly, Thigh/knee/shank/ankle/foot, External |
| Applicant | BESCO FINANCIAL SERVICE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KFX |
| CFR Regulation Number | 890.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-27 |
| Decision Date | 1983-03-09 |