70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER

Filter, Bacterial, Breathing-circuit

HSINER CO., LTD.

The following data is part of a premarket notification filed by Hsiner Co., Ltd. with the FDA for 70530-bactial/viral Filter, 70531-hmef, 70536-bacterial/viral Filter.

Pre-market Notification Details

Device IDK091185
510k NumberK091185
Device Name:70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
ClassificationFilter, Bacterial, Breathing-circuit
Applicant HSINER CO., LTD. 29201 VIA NORTE Temecula,  CA  92591
ContactTom Shanks
CorrespondentTom Shanks
HSINER CO., LTD. 29201 VIA NORTE Temecula,  CA  92591
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-23
Decision Date2009-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14712688057445 K091185 000
14712680057436 K091185 000

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