The following data is part of a premarket notification filed by Lossing Orthopedic, Inc. with the FDA for Distrac(tm) Table.
| Device ID | K900475 |
| 510k Number | K900475 |
| Device Name: | DISTRAC(TM) TABLE |
| Classification | Equipment, Traction, Powered |
| Applicant | LOSSING ORTHOPEDIC, INC. 777 HARDING STREET, N.E. M-4 P.O. BOX 18298 Minneapolis, MN 55418 |
| Contact | Susan G Wolf |
| Correspondent | Susan G Wolf LOSSING ORTHOPEDIC, INC. 777 HARDING STREET, N.E. M-4 P.O. BOX 18298 Minneapolis, MN 55418 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-01 |
| Decision Date | 1990-05-24 |