The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Integrated Cardioplegia Deliv. Sys.
Device ID | K810079 |
510k Number | K810079 |
Device Name: | SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS |
Classification | Accessory Equipment, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRI |
CFR Regulation Number | 870.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-13 |
Decision Date | 1981-01-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50699753002000 | K810079 | 000 |
50699753001966 | K810079 | 000 |
50699753001959 | K810079 | 000 |
50699753001942 | K810079 | 000 |
50699753001218 | K810079 | 000 |