The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Maggi Series Ultra. Needle, Biopsy/catheter Guides.
| Device ID | K882383 |
| 510k Number | K882383 |
| Device Name: | MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES |
| Classification | Device, Biopsy, Endomyocardial |
| 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 | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-09 |
| Decision Date | 1988-11-28 |