AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER

Filter, Bacterial, Breathing-circuit

GALEMED CORP.

The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Af Viral/bacterial Filter, Bf Viral/bacterial Filter.

Pre-market Notification Details

Device IDK132679
510k NumberK132679
Device Name:AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
ClassificationFilter, Bacterial, Breathing-circuit
Applicant GALEMED CORP. 29201 VIA NORTE Temecula,  CA  92591
ContactTom Shanks
CorrespondentTom Shanks
GALEMED CORP. 29201 VIA NORTE Temecula,  CA  92591
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-28
Decision Date2014-04-18

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