SKYLARK URO PROBE

Stimulator, Electrical, Non-implantable, For Incontinence

SKYLARK DEVICE & SYSTEMS CO., LTD

The following data is part of a premarket notification filed by Skylark Device & Systems Co., Ltd with the FDA for Skylark Uro Probe.

Pre-market Notification Details

Device IDK053007
510k NumberK053007
Device Name:SKYLARK URO PROBE
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant SKYLARK DEVICE & SYSTEMS CO., LTD 4F, 34, SEC. 3, CHUNG SHAN NORTH RD. Taipei,  TW 104
ContactGeorge Chiang
CorrespondentGeorge Chiang
SKYLARK DEVICE & SYSTEMS CO., LTD 4F, 34, SEC. 3, CHUNG SHAN NORTH RD. Taipei,  TW 104
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-26
Decision Date2005-12-05
Summary:summary

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