Q2 Blood Administration Sets

Set, Administration, Intravascular

Quest Medical, Inc.

The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Q2 Blood Administration Sets.

Pre-market Notification Details

Device IDK213846
510k NumberK213846
Device Name:Q2 Blood Administration Sets
ClassificationSet, Administration, Intravascular
Applicant Quest Medical, Inc. One Allentown Parkway Allen,  TX  75002
ContactTosan Eweka
CorrespondentTosan Eweka
Quest Medical, Inc. One Allentown Parkway Allen,  TX  75002
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-10
Decision Date2022-06-05

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