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FDA 510(k) Application Details - K112562
Device Classification Name
More FDA Info for this Device
510(K) Number
K112562
Device Name
BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
Applicant
KIMBERLY-CLARK
1400 HOLCOMB BRIDGE ROAD
ROSWELL, GA 30076 US
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Contact
DAVID LEE
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OYI
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More FDA Info for this Product Code
Date Received
09/26/2011
Decision Date
12/15/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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