STERI-CATH(TM)

Catheters, Suction, Tracheobronchial

CONCORD/PORTEX

The following data is part of a premarket notification filed by Concord/portex with the FDA for Steri-cath(tm).

Pre-market Notification Details

Device IDK902383
510k NumberK902383
Device Name:STERI-CATH(TM)
ClassificationCatheters, Suction, Tracheobronchial
Applicant CONCORD/PORTEX 15 KITT ST. Keene,  NH  03431
ContactRobert Wheeler
CorrespondentRobert Wheeler
CONCORD/PORTEX 15 KITT ST. Keene,  NH  03431
Product CodeBSY  
CFR Regulation Number868.6810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-30
Decision Date1990-07-12

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