Chemfort CSTD

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 Chemfort Cstd.

Pre-market Notification Details

Device IDK192866
510k NumberK192866
Device Name:Chemfort CSTD
ClassificationClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant Simplivia Healthcare Ltd. North Industrial Zone Kiryat Shmona,  IL 1101801
ContactItsik Shmueli
CorrespondentRoger Gray
Donawa Lifescience Consulting Piazza Albania 10 Rome,  IT 00153
Product CodeONB  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-07
Decision Date2020-05-07

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