Sunmed Disposable Angio-Closure Pads

Clamp, Vascular

Sunny Medical Device (Shenzhen) Co.,Ltd.

The following data is part of a premarket notification filed by Sunny Medical Device (shenzhen) Co.,ltd. with the FDA for Sunmed Disposable Angio-closure Pads.

Pre-market Notification Details

Device IDK191827
510k NumberK191827
Device Name:Sunmed Disposable Angio-Closure Pads
ClassificationClamp, Vascular
Applicant Sunny Medical Device (Shenzhen) Co.,Ltd. 56 Lehigh Aisle Irvine,  CA  92612
ContactJames Qi Zhang
CorrespondentJames Qi Zhang
Sunny Medical Device (Shenzhen) Co.,Ltd. 56 Lehigh Aisle Irvine,  CA  92612
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-08
Decision Date2020-03-16

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