The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Turbo Membrane Oxygena. W/int. Reservoir.
| Device ID | K925075 |
| 510k Number | K925075 |
| Device Name: | SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Contact | Denise D Shimokochi |
| Correspondent | Denise D Shimokochi 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO 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 | 1992-10-07 |
| Decision Date | 1993-06-07 |