GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS

Cover, Barrier, Protective

GUANGZHOU FORTUNIQUE LTD.

The following data is part of a premarket notification filed by Guangzhou Fortunique Ltd. with the FDA for Guangzhou Fortunique Drapes, Bags And Covers.

Pre-market Notification Details

Device IDK041501
510k NumberK041501
Device Name:GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS
ClassificationCover, Barrier, Protective
Applicant GUANGZHOU FORTUNIQUE LTD. 485 LAROE ROAD Chester,  NY  10918
ContactJane B Campbell
CorrespondentJane B Campbell
GUANGZHOU FORTUNIQUE LTD. 485 LAROE ROAD Chester,  NY  10918
Product CodeMMP  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-07
Decision Date2004-11-30
Summary:summary

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