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 |