The following data is part of a premarket notification filed by Acra Cut, Inc. with the FDA for Automatic Cranial Drill (perforator).
| Device ID | K892866 |
| 510k Number | K892866 |
| Device Name: | AUTOMATIC CRANIAL DRILL (PERFORATOR) |
| Classification | Drills, Burrs, Trephines & Accessories (compound, 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 | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-19 |
| Decision Date | 1989-06-15 |