The following data is part of a premarket notification filed by Acra Cut, Inc. with the FDA for Bone Pad Remover.
| Device ID | K910225 |
| 510k Number | K910225 |
| Device Name: | BONE PAD REMOVER |
| Classification | Instrument, Surgical, Non-powered |
| Applicant | ACRA CUT, INC. 989 MAIN ST. Acton, MA 01720 |
| Contact | John W Baker |
| Correspondent | John W Baker ACRA CUT, INC. 989 MAIN ST. Acton, MA 01720 |
| Product Code | HAO |
| CFR Regulation Number | 882.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-18 |
| Decision Date | 1991-02-12 |