The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Ultipore Prebypass Plus Filter.
| Device ID | K831286 |
| 510k Number | K831286 |
| Device Name: | ULTIPORE PREBYPASS PLUS FILTER |
| Classification | Filter, Prebypass, Cardiopulmonary Bypass |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRJ |
| CFR Regulation Number | 870.4280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-20 |
| Decision Date | 1983-06-08 |