The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Turbo Membrane Oxygenator Modification.
| Device ID | K941653 |
| 510k Number | K941653 |
| Device Name: | SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | John W Toigo |
| Correspondent | John W Toigo 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 | 1994-04-05 |
| Decision Date | 1994-08-24 |