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 |