The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Mediastinal And Pericardial Tube.
Device ID | K792070 |
510k Number | K792070 |
Device Name: | SARNS MEDIASTINAL AND PERICARDIAL TUBE |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-15 |
Decision Date | 1979-11-21 |