The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Cdi H/s Cuvettes With Heparon Treatment.
| Device ID | K973472 |
| 510k Number | K973472 |
| Device Name: | 3M CDI H/S CUVETTES WITH HEPARON TREATMENT |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE 1311 VALENCIA AVE. Tustin, CA 92780 |
| Contact | Diana Rhea |
| Correspondent | Diana Rhea 3M HEALTH CARE 1311 VALENCIA AVE. Tustin, CA 92780 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-12 |
| Decision Date | 1997-12-08 |
| Summary: | summary |