The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Hilan Motor System.
| Device ID | K973736 |
| 510k Number | K973736 |
| Device Name: | AESCULAP HILAN MOTOR SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Contact | Mary E Holden |
| Correspondent | Mary E Holden AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-01 |
| Decision Date | 1997-12-29 |
| Summary: | summary |