The following data is part of a premarket notification filed by Acra Cut, Inc. with the FDA for Acra-cut Xpress 120.
| Device ID | K032970 |
| 510k Number | K032970 |
| Device Name: | ACRA-CUT XPRESS 120 |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Applicant | ACRA CUT, INC. 74 SPRING ROAD Amherst, NH 03031 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll ACRA CUT, INC. 74 SPRING ROAD Amherst, NH 03031 |
| Product Code | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-23 |
| Decision Date | 2003-12-08 |
| Summary: | summary |