PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS

Connector, Airway (extension)

PRIMA, INC.

The following data is part of a premarket notification filed by Prima, Inc. with the FDA for Prima, Inc. Connectors And Airway Extensions.

Pre-market Notification Details

Device IDK944534
510k NumberK944534
Device Name:PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
ClassificationConnector, Airway (extension)
Applicant PRIMA, INC. 1300 25TH ST. PLAZA SUITE 11 Cleveland,  TN  37311
ContactLoretta J Hart
CorrespondentLoretta J Hart
PRIMA, INC. 1300 25TH ST. PLAZA SUITE 11 Cleveland,  TN  37311
Product CodeBZA  
CFR Regulation Number868.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-15
Decision Date1994-11-29

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