The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Sarns Sm03 Membrane Oxygenator W/ Integrated Reser.
| Device ID | K912920 |
| 510k Number | K912920 |
| Device Name: | SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Contact | Cathy L Simpson |
| Correspondent | Cathy L Simpson 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-03 |
| Decision Date | 1991-09-25 |