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

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