FILTRAY 2G Disposable Water Filters

System, Water Purification, General Medical Use

Aqua-tools

The following data is part of a premarket notification filed by Aqua-tools with the FDA for Filtray 2g Disposable Water Filters.

Pre-market Notification Details

Device IDK191563
510k NumberK191563
Device Name:FILTRAY 2G Disposable Water Filters
ClassificationSystem, Water Purification, General Medical Use
Applicant aqua-tools 26, Rue Charles Edouard Jeanneret Poissy,  FR 78300
ContactVirginie S. Grondin
CorrespondentVirginie S. Grondin
aqua-tools 26, Rue Charles Edouard Jeanneret Poissy,  FR 78300
Product CodeNHV  
CFR Regulation Number876.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-13
Decision Date2019-10-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03760279731070 K191563 000
03760279730400 K191563 000
03760279730004 K191563 000
03760279733500 K191563 000
03760279733470 K191563 000
03760279733449 K191563 000
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03760279733371 K191563 000
03760279733333 K191563 000
03760279733296 K191563 000
03760279733265 K191563 000
03760279730431 K191563 000
03760279730547 K191563 000
03760279730370 K191563 000
03760279731063 K191563 000
03760279731056 K191563 000
03760279731049 K191563 000
03760279731032 K191563 000
03760279731025 K191563 000
03760279731018 K191563 000
03760279731001 K191563 000
03760279730998 K191563 000
03760279730981 K191563 000
03760279730455 K191563 000
03760279733234 K191563 000

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