The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Filter, Extracorporeal Blood Holder.
| Device ID | K781861 |
| 510k Number | K781861 |
| Device Name: | FILTER, EXTRACORPOREAL BLOOD HOLDER |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | SURGIKOS, INC. 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 | 1978-11-06 |
| Decision Date | 1978-11-15 |