Blue Beacon Submucosal Injectable Solution

Submucosal Injection Agent

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 Blue Beacon Submucosal Injectable Solution.

Pre-market Notification Details

Device IDK200071
510k NumberK200071
Device Name:Blue Beacon Submucosal Injectable Solution
ClassificationSubmucosal Injection Agent
Applicant Micro-Tech (Nanjing) Co., Ltd. NO. 10 Gaoke Third Road Nanjing,  CN 210032
ContactSally He
CorrespondentSally He
Micro-Tech (Nanjing) Co., Ltd. NO. 10 Gaoke Third Road Nanjing,  CN 210032
Product CodePLL  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-13
Decision Date2020-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16932503562529 K200071 000
16932503562512 K200071 000

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