The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Entrax Traction Unit.
| Device ID | K780763 |
| 510k Number | K780763 |
| Device Name: | ENTRAX TRACTION UNIT |
| Classification | Unit, Traction, Hip, Non-powered, Non-penetrating |
| Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HSR |
| CFR Regulation Number | 888.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-08 |
| Decision Date | 1978-05-16 |