The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for C-blade.
| Device ID | K802105 |
| 510k Number | K802105 |
| Device Name: | C-BLADE |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | CUTTER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-03 |
| Decision Date | 1980-09-16 |