EMODREN EXCHANGEABLE PLASTIC BELLOWS

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

PAREXEL INTL. CORP.

The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Emodren Exchangeable Plastic Bellows.

Pre-market Notification Details

Device IDK853295
510k NumberK853295
Device Name:EMODREN EXCHANGEABLE PLASTIC BELLOWS
ClassificationApparatus, Suction, Single Patient Use, Portable, Nonpowered
Applicant PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge,  MA  02138
ContactJulian P Kaye
CorrespondentJulian P Kaye
PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge,  MA  02138
Product CodeGCY  
CFR Regulation Number878.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-06
Decision Date1985-08-20

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