Foley Balloon Catheter For Urology

Catheter, Retention Type, Balloon

Apollon Co., Ltd.

The following data is part of a premarket notification filed by Apollon Co., Ltd. with the FDA for Foley Balloon Catheter For Urology.

Pre-market Notification Details

Device IDK201776
510k NumberK201776
Device Name:Foley Balloon Catheter For Urology
ClassificationCatheter, Retention Type, Balloon
Applicant Apollon Co., Ltd. M-1804/3203, 32, Songdogwahak-ro, Yeonsu-gu Incheon,  KR 21984
ContactDonghyuk Shin
CorrespondentHyeyoung Moon
TSD Life Sciences Co., Ltd. 211, Mallijae-ro, Jung-gu Seoul,  KR 04508
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-29
Decision Date2020-12-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800109200033 K201776 000
18800109201563 K201776 000
18800109201570 K201776 000
18800109201587 K201776 000
18800109201594 K201776 000
18800109201600 K201776 000
18800109201617 K201776 000
18800109201624 K201776 000
18800109201631 K201776 000
18800109201532 K201776 000
18800109201549 K201776 000
08800109201528 K201776 000
08800109201511 K201776 000
18800109201556 K201776 000

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