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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K171132
Device Name Carefusion NeutraClear Needle-free connector
Applicant
Cair Lgl
1 Allee Des Chevreuils - Bois Dieu
Lissieu,  FR 69380
Applicant Contact Delphine Molinari
Correspondent
Wiesen Law Offices
420 Lexington Ave. - Suite 2400
New York,  NY  10170
Correspondent Contact IRVING WIESEN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/17/2017
Decision Date 07/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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