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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 K093229
Device Name CATHETER CONNECTIONS DUALCAP
Applicant
Catheter Connections, Inc.
25 White Pine Canyon Rd.
Park City,  UT  84060
Applicant Contact DONALD D SOLOMON
Correspondent
Catheter Connections, Inc.
25 White Pine Canyon Rd.
Park City,  UT  84060
Correspondent Contact DONALD D SOLOMON
Regulation Number880.5440
Classification Product Code
QBP  
Date Received10/14/2009
Decision Date 04/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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