The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Elan 4 Motor System.
| Device ID | K152960 |
| 510k Number | K152960 |
| Device Name: | ELAN 4 Motor System |
| Classification | Motor, Drill, Electric |
| Applicant | AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
| Contact | Peter Stoll |
| Correspondent | Peter Stoll AESCULAP, INC. 3773 CORPORATE PARKWAY Center Valley, PA 18034 |
| Product Code | HBC |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-07 |
| Decision Date | 2016-07-22 |
| Summary: | summary |