The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 9000 With Centrifugal Pump Option.
Device ID | K884659 |
510k Number | K884659 |
Device Name: | SARNS 9000 WITH CENTRIFUGAL PUMP OPTION |
Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Contact | W O'donnell |
Correspondent | W O'donnell 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Product Code | KFM |
CFR Regulation Number | 870.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-07 |
Decision Date | 1989-01-24 |