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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Bronchoscopic Bronchoalveolar Lavage Catheter
510(k) Number K112562
Device Name BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
Applicant
Kimberly-Clark
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Applicant Contact DAVID LEE
Correspondent
Kimberly-Clark
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Correspondent Contact DAVID LEE
Regulation Number868.6810
Classification Product Code
OYI  
Date Received09/26/2011
Decision Date 12/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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