Polypectomy Snare

Snare, Flexible

MICRO- TECH (NANJING) CO., LTD.

The following data is part of a premarket notification filed by Micro- Tech (nanjing) Co., Ltd. with the FDA for Polypectomy Snare.

Pre-market Notification Details

Device IDK150316
510k NumberK150316
Device Name:Polypectomy Snare
ClassificationSnare, Flexible
Applicant MICRO- TECH (NANJING) CO., LTD. NO. 10 GAOKE THIRD ROAD Nanjing,  CN 210032
ContactBecky Li
CorrespondentBecky Li
MICRO- TECH (NANJING) CO., LTD. NO. 10 GAOKE THIRD ROAD Nanjing,  CN 210032
Product CodeFDI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-09
Decision Date2015-07-30
Summary:summary

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