The following data is part of a premarket notification filed by Surgiquip, Inc. with the FDA for Snap Bone Reamer.
| Device ID | K935322 |
| 510k Number | K935322 |
| Device Name: | SNAP BONE REAMER |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | SURGIQUIP, INC. 1799 E. 71ST ST. Tulsa, OK 74136 |
| Contact | Mary Biggers |
| Correspondent | Mary Biggers SURGIQUIP, INC. 1799 E. 71ST ST. Tulsa, OK 74136 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-04 |
| Decision Date | 1994-01-28 |