The following data is part of a premarket notification filed by Ortho-cast, Inc. with the FDA for Orthosis Bandages.
| Device ID | K810877 |
| 510k Number | K810877 |
| Device Name: | ORTHOSIS BANDAGES |
| Classification | Bandage, Cast |
| Applicant | ORTHO-CAST, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITG |
| CFR Regulation Number | 890.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-31 |
| Decision Date | 1981-04-17 |