OnGuard2 Chemfort Closed Administration (CADM)

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Simplivia Healthcare LTD.

The following data is part of a premarket notification filed by Simplivia Healthcare Ltd. with the FDA for Onguard2 Chemfort Closed Administration (cadm).

Pre-market Notification Details

Device IDK210707
510k NumberK210707
Device Name:OnGuard2 Chemfort Closed Administration (CADM)
ClassificationClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant Simplivia Healthcare LTD. North Industrial Zone Kiryat Shmona,  IL 1101801
ContactShay Shaham
CorrespondentShay Shaham
Simplivia Healthcare LTD. North Industrial Zone Kiryat Shmona,  IL 1101801
Product CodeONB  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-10
Decision Date2021-09-23

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