The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Civco/kempf Aspiration/biopsy/dialysis Needle.
| Device ID | K862481 |
| 510k Number | K862481 |
| Device Name: | CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. 418 B AVE. Kalona, IA 52247 |
| Contact | Victor Wedel |
| Correspondent | Victor Wedel CIVCO MEDICAL INSTRUMENTS CO., INC. 418 B AVE. Kalona, IA 52247 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-30 |
| Decision Date | 1986-07-23 |