The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Civco Stepper.
| Device ID | K871413 |
| 510k Number | K871413 |
| Device Name: | CIVCO STEPPER |
| Classification | Guide, Surgical, Instrument |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 418 B AVE. Kalona, IA 52247 |
| Contact | Victor J Wedel |
| Correspondent | Victor J Wedel CIVCO MEDICAL INSTRUMENTS CO., INC. 418 B AVE. Kalona, IA 52247 |
| Product Code | FZX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-08 |
| Decision Date | 1987-07-14 |