The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Modified Sarns Membrane Oxygenator.
| Device ID | K863902 |
| 510k Number | K863902 |
| Device Name: | MODIFIED SARNS MEMBRANE OXYGENATOR |
| Classification | Gas Control Unit, 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 | DTX |
| CFR Regulation Number | 870.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-07 |
| Decision Date | 1986-12-11 |