The following data is part of a premarket notification filed by Acra Cut, Inc. with the FDA for Acra-cut Neurological Surgical Device-powered.
| Device ID | K911819 |
| 510k Number | K911819 |
| Device Name: | ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED |
| Classification | Drills, Burrs, Trephines & Accessories (simple, 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 | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-24 |
| Decision Date | 1991-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810607000415 | K911819 | 000 |
| 00810607000408 | K911819 | 000 |
| 00810607000392 | K911819 | 000 |
| 00810607000385 | K911819 | 000 |