DISPOSABLE SILICONE FOLEY CATHETER

Catheter, Retention Type, Balloon

GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD

The following data is part of a premarket notification filed by Guangdong Baihe Medical Technology Co., Ltd with the FDA for Disposable Silicone Foley Catheter.

Pre-market Notification Details

Device IDK130908
510k NumberK130908
Device Name:DISPOSABLE SILICONE FOLEY CATHETER
ClassificationCatheter, Retention Type, Balloon
Applicant GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD PO BOX 120-119 Shanghai,  CN 200120
ContactDiana Hong
CorrespondentDiana Hong
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD PO BOX 120-119 Shanghai,  CN 200120
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-01
Decision Date2013-10-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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26938634494866 K130908 000
26938634494859 K130908 000
26938634494842 K130908 000
26938634484164 K130908 000

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