POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES

Tube, Tracheal (w/wo Connector)

POLAMEDCO, INC.

The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Polamedco Tracheal And Nasotracheal Tubes.

Pre-market Notification Details

Device IDK920900
510k NumberK920900
Device Name:POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES
ClassificationTube, Tracheal (w/wo Connector)
Applicant POLAMEDCO, INC. 8295 S.LA CIENEGA BLVD. Inglewood,  CA  90301 -1521
ContactDarrell Rogers
CorrespondentDarrell Rogers
POLAMEDCO, INC. 8295 S.LA CIENEGA BLVD. Inglewood,  CA  90301 -1521
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-26
Decision Date1992-03-18

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