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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
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