Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler And Reloads, Disposable Linear Cutter Stapler And Reloads, Disposable Endoscopic Linear Cutter Stapler And Reloads

Staple, Implantable

Beijing Biosis Healing Biological Technology Co., Ltd.

The following data is part of a premarket notification filed by Beijing Biosis Healing Biological Technology Co., Ltd. with the FDA for Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler And Reloads, Disposable Linear Cutter Stapler And Reloads, Disposable Endoscopic Linear Cutter Stapler And Reloads.

Pre-market Notification Details

Device IDK201639
510k NumberK201639
Device Name:Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler And Reloads, Disposable Linear Cutter Stapler And Reloads, Disposable Endoscopic Linear Cutter Stapler And Reloads
ClassificationStaple, Implantable
Applicant Beijing Biosis Healing Biological Technology Co., Ltd. Valley No.1 Bio-medicine Industry Park, Daxing District Beijing,  CN 102600
ContactTing Jiang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. BOX 120-119 Shanghai,  CN 200120
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-16
Decision Date2021-05-27

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.