The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Cardioplegia Plus Filter W/posidyne Membrane.
| Device ID | K875095 |
| 510k Number | K875095 |
| Device Name: | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE |
| Classification | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | Samuel Wortham |
| Correspondent | Samuel Wortham PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Product Code | JOD |
| CFR Regulation Number | 870.4270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-10 |
| Decision Date | 1988-02-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30887691000301 | K875095 | 000 |