The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Elan 4 Air Motor System.
| Device ID | K172907 |
| 510k Number | K172907 |
| Device Name: | ELAN 4 Air Motor System |
| Classification | Motor, Drill, Pneumatic |
| Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Jessica Stigliano |
| Correspondent | Jessica Stigliano Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2018-11-09 |
| Summary: | summary |