ENDURANCE R3000

Nebulizer (direct Patient Interface)

ESSENTIAL MEDICAL SUPPLY, INC.

The following data is part of a premarket notification filed by Essential Medical Supply, Inc. with the FDA for Endurance R3000.

Pre-market Notification Details

Device IDK942384
510k NumberK942384
Device Name:ENDURANCE R3000
ClassificationNebulizer (direct Patient Interface)
Applicant ESSENTIAL MEDICAL SUPPLY, INC. 6937-A STAPOINT COURT Winter Park,  FL  32792
ContactCarol A Hoepner
CorrespondentCarol A Hoepner
ESSENTIAL MEDICAL SUPPLY, INC. 6937-A STAPOINT COURT Winter Park,  FL  32792
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-19
Decision Date1994-12-19

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