BURLEW INFANT HOOD

Hood, Oxygen, Infant

PROMEDIC, INC.

The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Burlew Infant Hood.

Pre-market Notification Details

Device IDK962182
510k NumberK962182
Device Name:BURLEW INFANT HOOD
ClassificationHood, Oxygen, Infant
Applicant PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville,  IN  46055 -9501
ContactPaul E Dryden
CorrespondentPaul E Dryden
PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville,  IN  46055 -9501
Product CodeFOG  
CFR Regulation Number868.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-06
Decision Date1996-07-15
Summary:summary

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