SYSMEX SF-3000

Tubing, Fluid Delivery

SYSMEX CORP.

The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Sf-3000.

Pre-market Notification Details

Device IDK950508
510k NumberK950508
Device Name:SYSMEX SF-3000
ClassificationTubing, Fluid Delivery
Applicant SYSMEX CORP. 6699 RFD Long Grove,  IL  60047 -9596
ContactNina Gamperling
CorrespondentNina Gamperling
SYSMEX CORP. 6699 RFD Long Grove,  IL  60047 -9596
Product CodeFPK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-06
Decision Date1995-11-03

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