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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Device Disinfectant
510(k) Number K112985
Device Name CATHETER CONNECTIONS' DUALCAP DUO
Applicant
Catheter Connections, Inc.
2455 E Parleys Way - Suite 150
Salt Lake City,  UT  84109
Applicant Contact DONALD D SOLOMON
Correspondent
Catheter Connections, Inc.
2455 E Parleys Way - Suite 150
Salt Lake City,  UT  84109
Correspondent Contact DONALD D SOLOMON
Regulation Number880.5440
Classification Product Code
QBP  
Date Received10/06/2011
Decision Date 11/09/2011
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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