The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Sarns Non-filtered Venous Reservoir.
Device ID | K912915 |
510k Number | K912915 |
Device Name: | SARNS NON-FILTERED VENOUS RESERVOIR |
Classification | Defoamer, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
Contact | Cathy L Simpson |
Correspondent | Cathy L Simpson 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
Product Code | DTP |
CFR Regulation Number | 870.4230 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-03 |
Decision Date | 1991-09-25 |