The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Civco-super Scan/biopsy Guide.
| Device ID | K843573 |
| 510k Number | K843573 |
| Device Name: | CIVCO-SUPER SCAN/BIOPSY GUIDE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. P.O. BOX 182 Kalona , IA 52247 - |
| Contact | Victor J Wedel |
| Correspondent | Victor J Wedel CIVCO MEDICAL INSTRUMENTS CO., INC. P.O. BOX 182 Kalona , IA 52247 - |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-11 |
| Decision Date | 1984-12-13 |