The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Ultipor Sq40s Blood Transfusion Filter.
| Device ID | K811985 |
| 510k Number | K811985 |
| Device Name: | ULTIPOR SQ40S BLOOD TRANSFUSION FILTER |
| Classification | Microfilter, Blood Transfusion |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-13 |
| Decision Date | 1981-07-28 |