COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

Culture Media, Non-propagating Transport

COPAN ITALIA S.P.A.

The following data is part of a premarket notification filed by Copan Italia S.p.a. with the FDA for Copan Fecalswab Collection, Transport And Preservation System.

Pre-market Notification Details

Device IDK142094
510k NumberK142094
Device Name:COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
ClassificationCulture Media, Non-propagating Transport
Applicant COPAN ITALIA S.P.A. 62 FOREST STREE, SUITE 300 Marlborough,  MA  01752
ContactTina Wu
CorrespondentTina Wu
COPAN ITALIA S.P.A. 62 FOREST STREE, SUITE 300 Marlborough,  MA  01752
Product CodeJSM  
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-01
Decision Date2015-04-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
58053326002194 K142094 000
38053326000301 K142094 000
38053326000257 K142094 000
38053326002206 K142094 000

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