The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 800 Roller Pump.
Device ID | K953901 |
510k Number | K953901 |
Device Name: | SARNS 800 ROLLER PUMP |
Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Contact | Cheryl Rosenberg |
Correspondent | Cheryl Rosenberg 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO 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 |