The following data is part of a premarket notification filed by Warm & Form, Orthopedic Materials with the FDA for Cast Shoe, Cast Boot.
| Device ID | K830246 |
| 510k Number | K830246 |
| Device Name: | CAST SHOE, CAST BOOT |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | WARM & FORM, ORTHOPEDIC MATERIALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-25 |
| Decision Date | 1983-02-18 |