The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Blood Pump Model 7000.
Device ID | K780942 |
510k Number | K780942 |
Device Name: | BLOOD PUMP MODEL 7000 |
Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWB |
CFR Regulation Number | 870.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-07 |
Decision Date | 1978-06-19 |