The following data is part of a premarket notification filed by Amtech Scientific, Inc. with the FDA for Femoral Cement Removal Instrument.
| Device ID | K840735 |
| 510k Number | K840735 |
| Device Name: | FEMORAL CEMENT REMOVAL INSTRUMENT |
| Classification | Tap, Bone |
| Applicant | AMTECH SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HWX |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-21 |
| Decision Date | 1984-05-14 |