The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Membrane Oxygenator W/integral Reservoir.
| Device ID | K870829 |
| 510k Number | K870829 |
| Device Name: | SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Contact | Joseph W O'donnell |
| Correspondent | Joseph W O'donnell 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-05-06 |