The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Microspeed Uni Motor System.
| Device ID | K053526 |
| 510k Number | K053526 |
| Device Name: | MICROSPEED UNI MOTOR SYSTEM |
| Classification | Motor, Drill, Electric |
| 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 | HBC |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-19 |
| Decision Date | 2006-01-18 |
| Summary: | summary |