The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Infant Venous Reservoir Model #16387.
Device ID | K883345 |
510k Number | K883345 |
Device Name: | SARNS INFANT VENOUS RESERVOIR MODEL #16387 |
Classification | Reservoir, Blood, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
Contact | Denise Shimokochi |
Correspondent | Denise Shimokochi 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
Product Code | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-09 |
Decision Date | 1988-09-28 |