DEVILBISS MODEL 7351 SERIES

Attachment, Breathing, Positive End Expiratory Pressure

DEVILBISS HEALTH CARE, INC.

The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Devilbiss Model 7351 Series.

Pre-market Notification Details

Device IDK894424
510k NumberK894424
Device Name:DEVILBISS MODEL 7351 SERIES
ClassificationAttachment, Breathing, Positive End Expiratory Pressure
Applicant DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset,  PA  15501 -0635
ContactDavid Gast
CorrespondentDavid Gast
DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset,  PA  15501 -0635
Product CodeBYE  
CFR Regulation Number868.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-17
Decision Date1989-09-18

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