Safety Subcutaneous Infusion Set

Set, Administration, Intravascular

Epic Medical Pte. Ltd.

The following data is part of a premarket notification filed by Epic Medical Pte. Ltd. with the FDA for Safety Subcutaneous Infusion Set.

Pre-market Notification Details

Device IDK201626
510k NumberK201626
Device Name:Safety Subcutaneous Infusion Set
ClassificationSet, Administration, Intravascular
Applicant Epic Medical Pte. Ltd. 105 Cecil Street #20-04 The Octagon Singapore,  SG 069534
ContactFreddie Lee
CorrespondentRoshana Ahmed
QUARAS, LLC 25 Independence Blvd. Warren,  NJ  07059
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-16
Decision Date2021-03-24

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