PARI FILTER/VALVE SET

Nebulizer (direct Patient Interface)

PAUL RITZAU PARI-WERK GMBH

The following data is part of a premarket notification filed by Paul Ritzau Pari-werk Gmbh with the FDA for Pari Filter/valve Set.

Pre-market Notification Details

Device IDK926455
510k NumberK926455
Device Name:PARI FILTER/VALVE SET
ClassificationNebulizer (direct Patient Interface)
Applicant PAUL RITZAU PARI-WERK GMBH C/O MCGUIRE WOODS BATTLE/BOOTH 901 EAST CARY STREET Richmond,  VA  23219
ContactDeborah M Russell
CorrespondentDeborah M Russell
PAUL RITZAU PARI-WERK GMBH C/O MCGUIRE WOODS BATTLE/BOOTH 901 EAST CARY STREET Richmond,  VA  23219
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-24
Decision Date1993-09-28

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