FDA 510(k) Application Details - K112562

Device Classification Name

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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
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Regulation Number

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Classification Product Code OYI
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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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