Andorate Auxiliary Water Connector, Andorate Valves Set

Endoscope Channel Accessory

Smartdata Suzhou Co., Ltd

The following data is part of a premarket notification filed by Smartdata Suzhou Co., Ltd with the FDA for Andorate Auxiliary Water Connector, Andorate Valves Set.

Pre-market Notification Details

Device IDK191231
510k NumberK191231
Device Name:Andorate Auxiliary Water Connector, Andorate Valves Set
ClassificationEndoscope Channel Accessory
Applicant Smartdata Suzhou Co., Ltd 4F, Block 7, 198#, Jinshan Rd Suzhou,  CN 215011
ContactCindy Ye
CorrespondentThomas Schorre
Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum,  FL  33155 -3708
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2019-05-08
Decision Date2019-06-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10816734021344 K191231 000
10816734022976 K191231 000
10816734022952 K191231 000
00849771041313 K191231 000

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