The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Sm03 Membrane Oxygenator, Modification.
| Device ID | K912078 |
| 510k Number | K912078 |
| Device Name: | SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Cathy L Simpson |
| Correspondent | Cathy L Simpson 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-10 |
| Decision Date | 1991-08-20 |