The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Conducer Heat Exchanger.
Device ID | K923311 |
510k Number | K923311 |
Device Name: | CONDUCER HEAT EXCHANGER |
Classification | Heat-exchanger, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Contact | Cathy L Simpson |
Correspondent | Cathy L Simpson 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Product Code | DTR |
CFR Regulation Number | 870.4240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-07 |
Decision Date | 1992-09-18 |