BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER

Non-bronchoscopic Bronchoalveolar Lavage Catheter

KIMBERLY-CLARK

The following data is part of a premarket notification filed by Kimberly-clark with the FDA for Bal Cath Bronchial Aspirate Sampling Catheter.

Pre-market Notification Details

Device IDK112562
510k NumberK112562
Device Name:BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
ClassificationNon-bronchoscopic Bronchoalveolar Lavage Catheter
Applicant KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell,  GA  30076
ContactDavid Lee
CorrespondentDavid Lee
KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell,  GA  30076
Product CodeOYI  
CFR Regulation Number868.6810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-26
Decision Date2011-12-15
Summary:summary

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