The following data is part of a premarket notification filed by Huestis Machine Corp. with the FDA for Posicast Immobilization System.
| Device ID | K926187 |
| 510k Number | K926187 |
| Device Name: | POSICAST IMMOBILIZATION SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | HUESTIS MACHINE CORP. 68 BUTTONWOOD ST. Bristol, RI 02809 |
| Contact | Terry Chwalk |
| Correspondent | Terry Chwalk HUESTIS MACHINE CORP. 68 BUTTONWOOD ST. Bristol, RI 02809 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-08 |
| Decision Date | 1994-04-15 |