The following data is part of a premarket notification filed by Orthopedic Technology, Inc. with the FDA for Vent-a-cast.
| Device ID | K843780 |
| 510k Number | K843780 |
| Device Name: | VENT-A-CAST |
| Classification | Component, Cast |
| Applicant | ORTHOPEDIC TECHNOLOGY, INC. 10101 S. STATE STREET Sandy , UT 84070 - |
| Contact | Randall M Christens |
| Correspondent | Randall M Christens ORTHOPEDIC TECHNOLOGY, INC. 10101 S. STATE STREET Sandy , UT 84070 - |
| Product Code | LGF |
| CFR Regulation Number | 888.5940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-26 |
| Decision Date | 1984-11-14 |