The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Conducer Cardioplegia Set Sith Mp4.
Device ID | K922992 |
510k Number | K922992 |
Device Name: | CONDUCER CARDIOPLEGIA SET SITH MP4 |
Classification | Catheter, Cannula And Tubing, Vascular, 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 | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-22 |
Decision Date | 1992-09-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50699753005476 | K922992 | 000 |