The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Leukocyte Removal Filter, Platelets.
| Device ID | K873667 |
| 510k Number | K873667 |
| Device Name: | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS |
| Classification | Microfilter, Blood Transfusion |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | Samuel T Wortham |
| Correspondent | Samuel T Wortham PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-10 |
| Decision Date | 1988-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30887691003852 | K873667 | 000 |
| 30887691000110 | K873667 | 000 |
| 30887691000196 | K873667 | 000 |
| 30887691000424 | K873667 | 000 |
| 30887691000493 | K873667 | 000 |
| 30887691000509 | K873667 | 000 |
| 30887691000530 | K873667 | 000 |
| 30887691000554 | K873667 | 000 |
| 30887691003845 | K873667 | 000 |
| 30887691000547 | K873667 | 000 |