The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Ultipor Pre-bypass Plus Filter W/posidyne Membrane.
| Device ID | K875094 |
| 510k Number | K875094 |
| Device Name: | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE |
| Classification | Filter, Prebypass, Cardiopulmonary Bypass |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | Sam Wortham |
| Correspondent | Sam Wortham PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Product Code | KRJ |
| CFR Regulation Number | 870.4280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-10 |
| Decision Date | 1988-02-29 |