The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Elan 4 Tools.
| Device ID | K182527 |
| 510k Number | K182527 |
| Device Name: | ELAN 4 Tools |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A. Racosky |
| Correspondent | Kathy A. Racosky Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-14 |
| Decision Date | 2019-01-19 |
| Summary: | summary |