PUGGLE Enteral Feeding Pump And Feeding Set

Pump, Infusion, Enteral

Amsino International Inc.

The following data is part of a premarket notification filed by Amsino International Inc. with the FDA for Puggle Enteral Feeding Pump And Feeding Set.

Pre-market Notification Details

Device IDK200051
510k NumberK200051
Device Name:PUGGLE Enteral Feeding Pump And Feeding Set
ClassificationPump, Infusion, Enteral
Applicant Amsino International Inc. 708 Corporate Center Drive Pomona,  CA  91768
ContactJane Gao
CorrespondentJane Gao
Amsino International Inc. 708 Corporate Center Drive Pomona,  CA  91768
Product CodeLZH  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-10
Decision Date2020-09-25

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