The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Leukocyte Removal Filter, Blood.
Device ID | K873666 |
510k Number | K873666 |
Device Name: | PALL LEUKOCYTE REMOVAL FILTER, BLOOD |
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 |
---|---|---|
30887691003869 | K873666 | 000 |
30887691000738 | K873666 | 000 |
30887691000592 | K873666 | 000 |
30887691000585 | K873666 | 000 |
30887691000165 | K873666 | 000 |
30887691000172 | K873666 | 000 |