The following data is part of a premarket notification filed by Lossing Orthopedic, Inc. with the FDA for Prom Naid.
| Device ID | K843581 |
| 510k Number | K843581 |
| Device Name: | PROM NAID |
| Classification | Equipment, Traction, Powered |
| Applicant | LOSSING ORTHOPEDIC, INC. 2217 NICOLLET AVENUE Minneapolis , MN 55404 - |
| Contact | Susan G Wolf |
| Correspondent | Susan G Wolf LOSSING ORTHOPEDIC, INC. 2217 NICOLLET AVENUE Minneapolis , MN 55404 - |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-11 |
| Decision Date | 1984-12-11 |