PALL LEUKOCYTE REMOVAL FILTER, BLOOD

Microfilter, Blood Transfusion

PALL BIOMEDICAL PRODUCTS CO.

The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Leukocyte Removal Filter, Blood.

Pre-market Notification Details

Device IDK873666
510k NumberK873666
Device Name:PALL LEUKOCYTE REMOVAL FILTER, BLOOD
ClassificationMicrofilter, Blood Transfusion
Applicant PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove,  NY  11542
ContactSamuel T Wortham
CorrespondentSamuel T Wortham
PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove,  NY  11542
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-10
Decision Date1988-01-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30887691003869 K873666 000
30887691000738 K873666 000
30887691000592 K873666 000
30887691000585 K873666 000
30887691000165 K873666 000
30887691000172 K873666 000

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