The following data is part of a premarket notification filed by Aesculap Instruments Corp. with the FDA for Robotrac (tm) Retractor Arm.
| Device ID | K893121 |
| 510k Number | K893121 |
| Device Name: | ROBOTRAC (TM) RETRACTOR ARM |
| Classification | Retractor |
| Applicant | AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
| Contact | Robin Bush |
| Correspondent | Robin Bush AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-06-01 |