The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-medicus Cannula Introducer.
| Device ID | K903410 |
| 510k Number | K903410 |
| Device Name: | BIO-MEDICUS CANNULA INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Contact | Thomas Johnsen |
| Correspondent | Thomas Johnsen BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-10-31 |