The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Sarns 9000 Universal Roller Pump.
| Device ID | K953904 |
| 510k Number | K953904 |
| Device Name: | SARNS 9000 UNIVERSAL ROLLER PUMP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Applicant | 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Contact | Cheryl Rosenberg |
| Correspondent | Cheryl Rosenberg 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Product Code | DWB |
| CFR Regulation Number | 870.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-18 |
| Decision Date | 1996-04-19 |
| Summary: | summary |