The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Modified Sarns Oxygenator System.
Device ID | K863515 |
510k Number | K863515 |
Device Name: | MODIFIED SARNS OXYGENATOR SYSTEM |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Contact | Marshall Smith |
Correspondent | Marshall Smith 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-10 |
Decision Date | 1986-11-18 |