ENTERAL ONLY EXTENSION SET

Tubes, Gastrointestinal (and Accessories)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Enteral Only Extension Set.

Pre-market Notification Details

Device IDK082654
510k NumberK082654
Device Name:ENTERAL ONLY EXTENSION SET
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
ContactAndrew P Zeltwanger
CorrespondentAndrew P Zeltwanger
RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-12
Decision Date2008-11-25
Summary:summary

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