PANTHER Endo Linear Cutter Staplers With Single Use Loading Units

Staple, Implantable

B.J.Z.H.F. Panther Medical Equipment Co. Ltd.

The following data is part of a premarket notification filed by B.j.z.h.f. Panther Medical Equipment Co. Ltd. with the FDA for Panther Endo Linear Cutter Staplers With Single Use Loading Units.

Pre-market Notification Details

Device IDK142577
510k NumberK142577
Device Name:PANTHER Endo Linear Cutter Staplers With Single Use Loading Units
ClassificationStaple, Implantable
Applicant B.J.Z.H.F. Panther Medical Equipment Co. Ltd. ROM 805, Ruichuang Mansion, NO. 9 Wangjing East Beijing,  CN
ContactLiu Yu
CorrespondentChu Xiaoan
CHU XIAOAN Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan ZhongRd Beijing,  CN
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-12
Decision Date2015-06-11
Summary:summary

NIH GUDID Devices

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