The following data is part of a premarket notification filed by Altoona Medical Supply with the FDA for Flexion Distration Support.
| Device ID | K921711 |
| 510k Number | K921711 |
| Device Name: | FLEXION DISTRATION SUPPORT |
| Classification | Accessories, Traction |
| Applicant | ALTOONA MEDICAL SUPPLY 705 2ND AVE., S.W. Altoona, IA 50009 |
| Contact | Donald A Mackenzie |
| Correspondent | Donald A Mackenzie ALTOONA MEDICAL SUPPLY 705 2ND AVE., S.W. Altoona, IA 50009 |
| Product Code | ILZ |
| CFR Regulation Number | 890.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1992-07-13 |