The following data is part of a premarket notification filed by Huestis Machine Corp. with the FDA for Compu-cutter Therapeutic Shielding Cutting Device.
| Device ID | K940145 |
| 510k Number | K940145 |
| Device Name: | COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE |
| Classification | Accelerator, Linear, Medical |
| Applicant | HUESTIS MACHINE CORP. 68 BUTTONWOOD ST. Bristol, RI 02809 |
| Contact | Taras J Chwalk |
| Correspondent | Taras J 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 | 1994-01-03 |
| Decision Date | 1995-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850077007163 | K940145 | 000 |