Cleared Traditional

PUGGLE Enteral Feeding Pump and Feeding Set

K200051 · Amsino International, Inc. · General Hospital
Sep 2020
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K200051 is an FDA 510(k) clearance for the PUGGLE Enteral Feeding Pump and Feeding Set, a Pump, Infusion, Enteral (Class II — Special Controls, product code LZH), submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on September 25, 2020, 259 days after receiving the submission on January 10, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K200051 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2020
Decision Date September 25, 2020
Days to Decision 259 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZH — Pump, Infusion, Enteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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