The following data is part of a premarket notification filed by Advanced Med/surg, Inc. with the FDA for Cohort Bone Brush.
| Device ID | K942108 |
| 510k Number | K942108 |
| Device Name: | COHORT BONE BRUSH |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Contact | Ronald C Allen |
| Correspondent | Ronald C Allen ADVANCED MED/SURG, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-02 |
| Decision Date | 1994-10-11 |