The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for New Sterility Character/sarns Oxygenator Products.
| Device ID | K911227 |
| 510k Number | K911227 |
| Device Name: | NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Contact | Cathy L Simpson |
| Correspondent | Cathy L Simpson 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 | 1991-03-20 |
| Decision Date | 1991-05-29 |