The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Hypothermic Mycardial Protection Dev.
| Device ID | K832417 |
| 510k Number | K832417 |
| Device Name: | HYPOTHERMIC MYCARDIAL PROTECTION DEV |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-21 |
| Decision Date | 1983-10-20 |