The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-medicus Tubing Connectors.
| Device ID | K883956 |
| 510k Number | K883956 |
| Device Name: | BIO-MEDICUS TUBING CONNECTORS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Contact | John R Dalpee |
| Correspondent | John R Dalpee BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-19 |
| Decision Date | 1988-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20673978555267 | K883956 | 000 |
| 20673978555182 | K883956 | 000 |
| 20673978555199 | K883956 | 000 |
| 20673978555205 | K883956 | 000 |
| 20673978555229 | K883956 | 000 |
| 20673978555236 | K883956 | 000 |
| 20673978555243 | K883956 | 000 |
| 20673978555250 | K883956 | 000 |
| 20673978555274 | K883956 | 000 |
| 20673978555281 | K883956 | 000 |
| 20673978555311 | K883956 | 000 |
| 20673978555328 | K883956 | 000 |
| 20673978555335 | K883956 | 000 |
| 20673978555342 | K883956 | 000 |
| 20673978555175 | K883956 | 000 |