Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B

Endoscope Channel Accessory

Wilson Instruments (SHA) Co., LTD

The following data is part of a premarket notification filed by Wilson Instruments (sha) Co., Ltd with the FDA for Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B.

Pre-market Notification Details

Device IDK200769
510k NumberK200769
Device Name:Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
ClassificationEndoscope Channel Accessory
Applicant Wilson Instruments (SHA) Co., LTD Building 5, No. 258 Shuangbang Rd. Xujing Town Qingpu Dist Shanghai,  CN 201702
ContactJuan Wu
CorrespondentJuan Wu
Wilson Instruments (SHA) Co., LTD Building 5, No. 258 Shuangbang Rd. Xujing Town Qingpu Dist Shanghai,  CN 201702
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-25
Decision Date2021-01-06

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